Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing pathogens ( i.e., H. influenzae and M. catarrhalis, H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL) as follows [see...
The recommended dosage and administration for the amoxicillin and clavulanate potassium for oral suspension, depends on the indication, patient age, weight, and ability to swallow tablets. Therefore, carefully follow the recommended dosage and administration instructions specified below [see Dosage and Administration (2.2 , 2.5 to 2.8) ]. Amoxicillin and clavulanate potassium for oral suspension is not recommended...
How Supplied Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: 600 mg/42.9 mg per 5 mL: White to off-white, strawberry-flavored powder for oral suspension. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin USP as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium). Bottles of 75 mL NDC 65862-535-75 Bott...
www.fda.gov/medwatchwww.fda.gov/STICAmoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing pathogens (i.e., H. influenzae and M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL) as follows [see Use in Specific Populations (8.4), Clinical Studies (14.4)]:
Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of recurrent or persistent acute otitis media due to confirmed or suspected S. pneumoniae (MICs less than or equal to 2 mcg/mL), H. influenzae or M. catarrhalis (including beta-lactamase-producing strains) in pediatric patients 3 months to 2 years of age (or 2 to 12 years of age who attend daycare) weighing 8 kg to 40 kg and used an antibacterial drug for acute otitis media within the preceding 3 months [see Use in Specific Populations (8.4), Clinical Studies (14.6)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin and clavulanate potassium for oral suspension is not a substitute for AUGMENTIN Tablets in adults.
The recommended dosage for pediatric patients aged 3 months to 12 years and weighing 8 kg to 40 kg are provided in Table 3.
For pediatric patients weighing greater than 40 kg, experience with amoxicillin and clavulanate potassium for oral suspension is not available.
To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.
Table 3: Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients 3 Months to 12 Years and Weighing 8 kg to 40 kg
| Infection Type | Frequency | Dose (Amoxicillin component) | Formulation Strength |
| Amoxicillin and Clavulanate Potassium for Oral Suspension | |||
| Acute bacterial sinusitis Recurrent or persistent acute otitis mediaa
| Every 12 hours | 90 mg/kg/day divided into 2 doses | 600 mg/42.9 mgb
|
a The recommended duration of therapy for recurrent or persistent acute bacterial otitis media is 10 days
b Strength of amoxicillin/clavulanate potassium per 5 mL oral suspension
Amoxicillin and Clavulanate Potassium for Oral Suspension
A reduced dosage is recommended in patients with severe renal impairment (see Table 4). No dosage adjustment is recommended in patients with mild to moderate renal impairment.
Table 4: Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Patients with Severe Renal Impairment
| Patients with Severe Renal Impairment | Dosage |
| GFR 10 mL/min to less than 30 mL/min | 500 mg or 250 mg every 12 hours, depending on the severity of the infection |
| GFR less than 10 mL/min | 500 mg or 250 mg every 24 hours, depending on severity of the infection |
| Hemodialysis | 500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis |
Patients with a GFR of less than 30 mL/min should not receive the 875 mg/125 mg dose of amoxicillin and clavulanate potassium
Amoxicillin and Clavulanate Potassium for Oral Suspension
Patients with severe renal impairment or those on intermittent hemodialysis should not receive amoxicillin and clavulanate potassium for oral suspension [see Use in Specific Populations (8.6)].
Prepare the oral suspension at time of dispensing as follows:
Flavoring Information:
For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, immediately after reconstitution, 1 drop of FLAVORx® (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension when mixed with flavors other than the 5 flavors listed above has not been evaluated.
Storage
Store reconstituted amoxicillin and clavulanate potassium for oral suspension under refrigeration; discard after 10 days. A slight color change during storage is normal.
Table 5: Amount of Water for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension
| Strength of Oral Suspension (amoxicillin/clavulanic acid) | Bottle Size | Amount of Water for Reconstitution |
| 600 mg/42.9 mg per 5 mL | 75 mL 125 mL 200 mL | 71 mL 112 mL 176 mL |
Amoxicillin and Clavulanate Potassium for Oral Suspension
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP
600 mg/42.9 mg per 5 mL: White to off-white, strawberry-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 600 mg of amoxicillin USP as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt).
Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin and clavulanate potassium, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Amoxicillin and clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions to amoxicillin, clavulanate, or to other beta-lactam antibacterial drugs [see Contraindications (4.1)]. If an allergic reaction occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
Amoxicillin and clavulanate potassium may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium discontinued if lesions progress.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium [see Adverse Reactions (6.2)], with most cases occurring in pediatric patients. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium. Hepatotoxicity is usually reversible; however, deaths have been reported. These cases have generally been associated with serious underlying diseases or concomitant medications. Amoxicillin and clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin and clavulanate potassium [see Contraindications (4.2), Use in Specific Populations (8.7), Adverse Reactions (6.2)].
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin- producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Avoid amoxicillin and clavulanate potassium use in patients with mononucleosis [see Adverse Reactions (6.2)].
The possibility of superinfections with mycotic or bacterial pathogens should be considered during therapy. If superinfections occur (commonly involving Pseudomonas spp. or Candida spp.), discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
Phenylalanine can be harmful to patients with phenylketonuria (PKU). Amoxicillin and clavulanate potassium for oral suspension contain aspartame, which is a source of phenylalanine. Each 5 mL of suspension of amoxicillin and clavulanate potassium for oral suspension contains 7.02 mg phenylalanine. Before prescribing the amoxicillin and clavulanate potassium for oral suspension to patients with PKU, consider the combined daily amount of phenylalanine from all sources, including amoxicillin and clavulanate potassium.
Prescribing amoxicillin and clavulanate potassium in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Amoxicillin and Clavulanate Potassium for Oral Suspension
Two clinical trials evaluated the safety of a 10-day treatment course of amoxicillin and clavulanate potassium for oral suspension 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with recurrent or persistent acute otitis media [see Clinical Studies (14.6)]. The first trial involved 521 pediatric patients (aged 3 months to 50 months), and the second trial involved 450 pediatric patients (aged 3 months to 12 years).
In the first trial, the most frequently reported adverse reactions were vomiting (7%), fever (6%), contact dermatitis (i.e., diaper rash) (6%), upper respiratory tract infection (4%), and diarrhea (4%). Diarrhea, defined in the protocol as ≥3 watery stools in one day or ≥2 watery stools per day for 2 consecutive days as recorded on diary cards, occurred in 13% of patients.
The primary objective of the second study was to compare the safety of amoxicillin and clavulanate potassium for oral suspension at 90/6.4 mg/kg/day, divided every 12 hours to AUGMENTIN for Oral Suspension at 45/6.4 mg/kg/day, divided every 12 hours for ten days. Adverse reactions were similar between treatment groups. The most frequently reported adverse reactions for amoxicillin and clavulanate potassium for oral suspension and the comparator were coughing (12% versus 7%), vomiting (7% versus 8%), contact dermatitis (i.e., diaper rash, 6% versus 5%), fever (6% versus 4%), and upper respiratory infection (3% versus 9%), respectively. Protocol-defined diarrhea occurred in 11% of patients receiving amoxicillin and clavulanate potassium for oral suspension and 9% of patients receiving the comparator; the difference was not statistically different. Two patients in the amoxicillin and clavulanate potassium for oral suspension group and one patient in the comparator group discontinued treatment due to diarrhea.
The following adverse reactions have been identified during postmarketing use of amoxicillin and clavulanate potassium products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.3, 5.5)].
Immune: Hypersensitivity reactions, anaphylactic reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1)].
Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis [see Warnings and Precautions (5.1, 5.2, 5.6)].
Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials. Hepatic dysfunction, including increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported [see Contraindications (4.2), Warnings and Precautions (5.4)].
Renal: Interstitial nephritis and hematuria have been reported. Crystalluria has also been reported [see Overdosage (10)].
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. There have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy concomitantly [see Drug Interactions (7.2)].
Central Nervous System: Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.
Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid is not recommended.
Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
The concurrent administration of allopurinol and amoxicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Discontinue allopurinol at the first appearance of skin rash when used concomitantly with amoxicillin and clavulanate potassium.
High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Therefore, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
Risk Summary
Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. A study in women with preterm prelabor rupture of membranes (PPROM) reported that prophylactic treatment with amoxicillin and clavulanate may be associated with an increased risk of necrotizing enterocolitis in neonates (see Data). Reproduction studies conducted in pregnant rats, given doses greater than or equal to 4 and 10 times the Maximum Recommended Human Dose (MRHD) of amoxicillin trihydrate and clavulanate respectively in amoxicillin and clavulanate potassium based on body surface area, revealed no evidence of fetal harm (see Data).
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data
Human Data
One randomized, controlled trial included 4,826 pregnant women with premature rupture of fetal membranes who were randomly assigned to 250 mg erythromycin (n=1,197), 250 mg amoxicillin and 125 mg clavulanate (n=1,212), amoxicillin and clavulanate plus erythromycin (n=1,192), or placebo (n=1,225) four times daily for 10 days or until delivery. Amoxicillin and clavulanate was associated with a significantly increased rate of proven neonatal necrotizing enterocolitis: 1.9% (n=24) in the amoxicillin and clavulanate only group versus 0.5% (n=6) in the placebo group (p=0.001), and 1.8% (n=44) in the any amoxicillin and clavulanate group versus 0.7% (n=17) in the no amoxicillin and clavulanate group (p=0.0005).
Animal Data
In an embryofetal developmental study in pregnant rats, amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) were administered at oral doses up to 1,200 mg/kg/day during the period of organogenesis (gestation days (GD) 6 to 15). No evidence of fetal harm was observed. Based on body surface area comparisons, the dose corresponds to approximately 4 times the MRHD for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium.
In a pre-and postnatal developmental study in pregnant rats, amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) were administered at oral doses up to 1,200 mg/kg/day beginning from GD 15 through Day 21 of lactation. No effects on maternal reproductive function or on developmental and reproductive parameters of the offspring were observed up to the highest dose, corresponding to approximately 4 times the MRHD for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium, based on body surface area comparisons.
Risk Summary
Data from a published clinical lactation study report that amoxicillin is present in human milk. There are reports of diarrhea, irritability, and rash in infants exposed to amoxicillin and clavulanate through breast milk; therefore, infants exposed to amoxicillin and clavulanate potassium should be monitored for these symptoms. There are no data on the effects of amoxicillin and clavulanate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for amoxicillin and clavulanate potassium and any potential adverse effects on the breastfed child from amoxicillin and clavulanate potassium or from the underlying maternal condition.
The five amoxicillin and clavulanate potassium dosage forms (tablets, chewable tablets, oral suspension, XR tablets, and 600 mg/42.9 mg per 5 mL for oral suspension) are different products. They are approved for different pediatric indications, age groups, and weights; have different dosing regimens; and have different preparation and administration instructions. Therefore, select the recommended dosage form based on the pediatric indication, age group, and weight [see Dosage and Administration (2)].
Acute Bacterial Sinusitis
The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing pathogens (i.e., H. influenzae and M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL) as follows [see Indications and Usage (1.3), Clinical Pharmacology (12.3), Clinical Studies (14.4)]:
Rec urrent or Persistent Acute Otitis Media
The safety and effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension is established for the treatment of recurrent or persistent acute otitis media due to confirmed or suspected S. pneumoniae (MICs less than or equal to 2 mcg/mL), H. influenzae or M. catarrhalis (including beta-lactamase-producing strains) in pediatric patients 3 months to 2 years of age (or 2 to 12 years of age who attend daycare) weighing 8 kg to 40 kg and used an antibacterial drug for acute otitis media within the preceding 3 months. Effectiveness is supported by adequate and well-controlled studies conducted in pediatric patients [see Indications and Usage (1.5), Clinical Pharmacology (12.3), Clinical Studies (14.6)].
Use Not Established in Certain Pediatric Populations
The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have not been established in the following pediatric populations:
Data are insufficient to support extrapolation in these age groups due to developmental differences in renal function. Elimination of amoxicillin may be delayed, while clavulanate elimination is not altered. Dosage should be modified in pediatric patients less than 12 weeks (3 months).
Amoxicillin and clavulanate potassium is substantially excreted by the kidney, and the risk of adverse reactions to amoxicillin and clavulanate potassium may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have renal impairment, monitor for adverse reactions. Dosage adjustment is recommended in patients with severe renal impairment [see Dosage and Administration (2.6), Use in Specific Populations (8.6)].
Amoxicillin is primarily eliminated by the kidney. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
Amoxicillin and Clavulanate Potassium for Oral Suspension
The pharmacokinetics of amoxicillin and clavulanate potassium for oral suspension have not been studied in patients with renal impairment. Patients with severe renal impairment (GFR less than 30 mL/min) and patients on intermittent hemodialysis should not receive amoxicillin and clavulanate potassium for oral suspension [see Dosage and Administration (2.6)].
Monitor hepatic function as appropriate during therapy with amoxicillin and clavulanate potassium [see Contraindications (4.2), Warnings and Precautions (5.4)].
Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.
In the case of overdosage, discontinue amoxicillin and clavulanate potassium for oral suspension, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying. 1 Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid).
Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.
Amoxicillin trihydrate has a molecular formula of C16H19N3O5S•3H2O, and a molecular weight of 419.46. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.
Clavulanate potassium has a molecular formula of C8H8KNO5 and a molecular weight of 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
Following reconstitution, each 5 mL of oral suspension contains 600 mg of amoxicillin USP (as amoxicillin trihydrate) and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium).
Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL contains 9 mg of potassium.
Amoxicillin and clavulanate potassium for oral suspension, USP is white to off-white granular powder and becomes white to pale yellow suspension with strawberry flavor after reconstitution.
Inactive Ingredients: Aspartame, colloidal silicon dioxide, hypromellose, silicon dioxide, strawberry cream permaseal, succinic acid, and xanthan gum [see Warnings and Precautions (5.8)].
Amoxicillin and clavulanate potassium is an antibacterial drug [see Clinical Pharmacology (12.4) ].
The antibacterial activity of amoxicillin/clavulanate is primarily driven by the percentage of the dosing interval during which unbound (free) amoxicillin plasma concentrations exceed the minimum inhibitory concentration (%fT>MIC) of the target bacterial organism. Clavulanate inhibits β-lactamase enzymes and thereby restores activity of amoxicillin against certain β-lactamase–producing bacteria.
Absorption
Amoxicillin and Clavulanate Potassium for Oral Suspension
The effect of food on amoxicillin and clavulanate potassium for oral suspension has not been formally evaluated. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in Table 10.
Distribution
The protein binding of amoxicillin and clavulanic acid to human serum is approximately 18% and 25%, respectively. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid.
Metabolism and Excretion
The half‑life of amoxicillin after the oral administration of amoxicillin and clavulanate potassium is approximately 1.3 hours and that of clavulanic acid is approximately 1 hour.
Amoxicillin and Clavulanate Potassium for Oral Suspension
Following administration of a single 250 mg/125 mg or 500 mg/125 mg tablet, approximately 50 to 70% of amoxicillin and approximately 25 to 40% of clavulanic acid are excreted unchanged in urine during the first 6 hours.
Specific Populations:
Pediatric Patients:
Amoxicillin and Clavulanate Potassium for Oral Suspension
The pharmacokinetics of amoxicillin and clavulanate potassium for oral suspension were evaluated in 19 pediatric patients (8 months to 11 years) receiving amoxicillin and clavulanate potassium for oral suspension at 45 mg/kg every 12 hours with a snack or meal. Mean pharmacokinetic parameters are listed in Table 10.
Table 10: Mean (±SD) Pharmacokinetic Parameters Following Administration of Amoxicillin and Clavulanate Potassium for Oral Suspension (45 mg/kg) Every 12 Hours in Pediatric Patients*
| Parameter | Amoxicillin | Clavulanate |
| Cmax (mcg/mL) | 15.7 ± 7.7 | 1.7 ± 0.9 |
| Tmax (hr) | 2 (1 to 4) | 1.1 (1 to 4) |
| AUC0-T (mcg*hr/mL) | 59.8 ± 20 | 4 ± 1.9 |
| T½ (hr) | 1.4 ± 0.3 | 1.1 ± 0.3 |
| CL/F (L/hr/kg) | 0.9 ± 0.4 | 1.1 ± 1.1 |
*Arithmetic mean ± standard deviation, except Tmax values which are medians (ranges).
Oral administration of a single dose of amoxicillin and clavulanate potassium for oral suspension at 45 mg/kg (based on the amoxicillin component) to pediatric patients (9 months to 8 years), yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF) (Table 11).
Table 11: Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Amoxicillin and Clavulanate Potassium for Oral Suspension (45 mg/kg) in Pediatric Patients*
| Timepoint | Amoxicillin concentration in plasma (mcg/mL) | Amoxicillin concentration in MEF (mcg/mL) | |
| 1 hour | mean median range | 7.7 9.3 1.5 to 14 (n=5) | 3.2 3.5 0.2 to 5.5 (n=4) |
| 2 hour | mean median range | 15.7 13 11 to 25 (n=7) | 3.3 2.4 1.9 to 6 (n=5) |
| 3 hour | mean median range | 13 12 5.5 to 21 (n=5) | 5.8 6.5 3.9 to 7.4 (n=5) |
*Dose administered immediately prior to eating.
Drug Interaction Studies
Clinical Studies
Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid [see Drug Interactions (7.1)].
Mechanism of Action
Amoxicillin binds to penicillin-binding proteins within the bacterial cell wall and inhibits bacterial cell wall synthesis. Clavulanic acid is a beta-lactam, structurally related to penicillin, that may inactivate certain beta‑lactamase enzymes.
Resistance
Resistance to penicillins may be mediated by destruction of the beta-lactam ring by a beta-lactamase, altered affinity of penicillin for target, or decreased penetration of the antibacterial drug to reach the target site. Amoxicillin alone is susceptible to degradation by beta‑lactamases, and therefore its spectrum of activity does not include bacteria that produce these enzymes.
Antimicrobial Activity
Amoxicillin and clavulanic acid has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1)].
Acute Bacterial Sinusitis
Gram-positive bacteria:
Staphylococcus aureus (methicillin-susceptible)
Streptococcus pneumoniae
Gram-negative bacteria:
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Recurrent or Persistent Acute Otitis Media
Gram-positive bacteria:
Streptococcus pneumoniae
Gram-negative bacteria:
Haemophilus influenzae
Moraxella catarrhalis
The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for amoxicillin and clavulanic acid against isolates of similar genus or organism group. However, the efficacy of amoxicillin and clavulanic acid in treating clinical infections caused by these bacteria have not been established in adequate and well-controlled trials.
Gram-positive bacteria:
Enterococcus faecalis
Staphylococcus epidermidis
Staphylococcus saprophyticus
Streptococcus pyogenes
Viridans group Streptococcus
Gram-negative Bacteria
Eikenella corrodens
Proteus mirabilis
Anaerobic Bacteria
Bacteroides species including Bacteroides fragilis
Fusobacterium species
Peptostreptococcus species
Susceptibility Testing:
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see www.fda.gov/STIC.
Carcinogenesis
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Mutagenesis
Amoxicillin and clavulanate (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at concentrations that were also associated with decreased cell survival. Amoxicillin and clavulanate was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Clavulanate potassium alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test and was negative in each of these assays.
Impairment of Fertility
Amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats. Based on body surface area comparisons, these doses correspond to approximately 4 times the MRHD for adults for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium.
Adults with a diagnosis of acute bacterial sinusitis (ABS) were evaluated in 3 clinical studies. In one study, 363 patients were randomized to receive either AUGMENTIN XR Extended-Release Tablets 2,000 mg/125 mg orally every 12 hours or levofloxacin 500 mg orally daily for 10 days in a double‑blind, multicenter, prospective trial. These patients were clinically and radiologically evaluated at the test of cure (day 17 to 28) visit. The combined clinical and radiological responses were 84% for AUGMENTIN XR Extended-Release Tablets and 84% for levofloxacin at the test of cure visit in clinically evaluable patients (95% CI for the treatment difference equals ‑9.4, 8.3). The clinical response rates at the test of cure were 87% and 89%, respectively.
The other 2 trials were non‑comparative, multicenter studies designed to assess the bacteriological and clinical efficacy of AUGMENTIN XR Extended-Release Tablets (2,000 mg/125 mg orally every 12 hours for 10 days) in the treatment of 2,288 patients with ABS. Evaluation timepoints were the same as in the prior study. Patients underwent maxillary sinus puncture for culture prior to receiving study medication. Patients with acute bacterial sinusitis due to S. pneumoniae with reduced susceptibility to penicillin were accrued through enrollment in these 2 open‑label non‑comparative clinical trials. Clinical success rates for key pathogens in these studies are shown in Table 15.
Table 15: Clinical Success Rates in Patients with Acute Bacterial Sinusitis
| Penicillin MICs of S. pneumoniae Isolates | Intent-To-Treat | Clinically Evaluable | ||||
| n/Na
| % | 95% CIb
| n/Na
| % | 95% CIb
| |
| All S. pneumoniae
| 344/370 | 93 | - | 318/326 | 98 | - |
| MIC greater than or equal to 2.0 mcg/mLc | 35/36 | 97 | 85.5, 99.9 | 30/31 | 96 | 83.3, 99.9 |
| MIC equal to 2.0 mcg/mL | 23/24 | 96 | 78.9, 99.9 | 19/20 | 95 | 75.1, 99.9 |
| MIC greater than or equal to 4.0 mcg/mLd | 12/12 | 100 | 73.5, 100 | 11/11 | 100 | 71.5, 100 |
| H. influenzae | 265/305 | 87 | - | 242/259 | 93 | - |
| M. catarrhalis | 94/105 | 90 | - | 86/90 | 96 | - |
an/N equals patients with pathogen eradicated or presumed eradicated/total number of patients.
bConfidence limits calculated using exact probabilities.
cS. pneumoniae strains with penicillin MICs of greater than or equal to 2 mcg/mL are considered resistant to penicillin.
dIncludes one patient each with S. pneumoniae penicillin MICs of 8 and 16 mcg/mL.
Two clinical studies were conducted in pediatric patients with acute otitis media. A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of amoxicillin and clavulanate potassium for oral suspension (90/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatric patients (3 to 50 months) with acute otitis media. The primary objective was to assess bacteriological response in pediatric patients with acute otitis media due to S. pneumoniae with amoxicillin/clavulanic acid MICs of 4 mcg/mL. The study sought the enrollment of patients with the following risk factors: Failure of antibacterial therapy for acute otitis media in the previous 3 months, history of recurrent episodes of acute otitis media, 2 years or younger, or day care attendance. Prior to receiving amoxicillin and clavulanate potassium for oral suspension, all patients had tympanocentesis to obtain middle ear fluid for bacteriological evaluation. Patients from whom S. pneumoniae (alone or in combination with other bacteria) was isolated had a second tympanocentesis 4 to 6 days after the start of therapy. Clinical assessments were planned for all patients during treatment (4 to 6 days after starting therapy), as well as 2 to 4 days post-treatment and 15 to 18 days post-treatment. Bacteriological success was defined as the absence of the pretreatment pathogen from the on-therapy tympanocentesis specimen. Clinical success was defined as improvement or resolution of signs and symptoms. Clinical failure was defined as lack of improvement or worsening of signs and/or symptoms at any time following at least 72 hours of amoxicillin and clavulanate potassium for oral suspension; patients who received an additional systemic antibacterial drug for otitis media after 3 days of therapy were considered clinical failures. Bacteriological eradication on therapy (day 4 to 6 visit) in the per protocol population is summarized in Table 17.
Table 17: Bacteriologic Eradication Rates in the Per Protocol Population
| Bacteriologic Eradication on Therapy | |||
| Pathogen | n/N | % | 95% CI* |
| All S. pneumoniae
| 121/123 | 98 | (94.3, 99.8) |
| S. pneumoniae with penicillin MIC equal to 2 mcg/mL | 19/19 | 100 | (82.4, 100.0) |
| S. pneumoniae with penicillin MIC equal to 4 mcg/mL | 12/14 | 86 | (57.2, 98.2) |
| H. influenzae | 75/81 | 93 | (84.6, 97.2) |
| M. catarrhalis | 11/11 | 100 | (71.5, 100.0) |
*CI equals confidence intervals; 95% CIs are not adjusted for multiple comparisons.
Clinical assessments were made in the per protocol population 2 to 4 days post-therapy and 15 to 18 days post-therapy. Patients who responded to therapy 2 to 4 days post-therapy were followed for 15 to 18 days post-therapy to assess them for acute otitis media. Non-responders at 2 to 4 days post-therapy were considered failures at the latter timepoint. The clinical assessments in the per protocol population are presented in Table 18.
Table 18: Clinical Assessments in the Per Protocol Population (Includes S. pneumoniae Patients with Penicillin MICs equal to 2 or 4 mcg/mL*)
| 2 to 4 Days Post-Therapy (Primary Endpoint) | |||
| Pathogen | n/N | % | 95% CI†
|
| All S. pneumoniae
| 122/137 | 89 | (82.6, 93.7) |
| S. pneumoniae with penicillin MIC equal to 2 mcg/mL | 17/20 | 85 | (62.1, 96.8) |
| S. pneumoniae with penicillin MIC equal to 4 mcg/mL | 11/14 | 79 | (49.2, 95.3) |
| H. influenzae | 141/162 | 87 | (80.9, 91.8) |
| M. catarrhalis | 22/26 | 85 | (65.1, 95.6) |
| 15 to 18 Days Post-Therapy‡ (Secondary Endpoint) | |||
| Pathogen | n/N | % | 95% CI†
|
| All S. pneumoniae
| 95/136 | 70 | (61.4, 77.4) |
| S. pneumoniae with penicillin MIC equal to 2 mcg/mL | 11/20 | 55 | (31.5, 76.9) |
| S. pneumoniae with penicillin MIC equal to 4 mcg/mL | 5/14 | 36 | (12.8, 64.9) |
| H. influenzae | 106/156 | 68 | (60, 75.2) |
| M. catarrhalis | 14/25 | 56 | (34.9, 75.6) |
*S. pneumoniae strains with penicillin MICs of 2 or 4 mcg/mL are considered resistant to penicillin.
†CI equals confidence intervals; 95% CIs are not adjusted for multiple comparisons.
‡Clinical assessments at 15 to 18 days post-therapy may have been confounded by viral infections and new episodes of acute otitis media with time elapsed post-treatment.
In the intent-to-treat analysis, overall clinical outcomes at 2 to 4 days and 15 to 18 days post- treatment in patients with S. pneumoniae with penicillin MIC equal to 2 mcg/mL and 4 mcg/mL were 29/41 (71%) and 17/41 (42%), respectively.
1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30:66-67.
How Supplied
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP:
600 mg/42.9 mg per 5 mL:White to off-white, strawberry-flavored powder for oral suspension. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin USP as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium).
Bottles of 75 mL NDC 65862-535-75
Bottles of 125 mL NDC 65862-535-13
Bottles of 200 mL NDC 65862-535-02
Storage
Powder for Oral Suspension
Store dry powder at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
Reconstituted Oral Suspension
Store reconstituted amoxicillin and clavulanate potassium for oral suspension in the original container under refrigeration. Discard unused reconstituted suspension after 10 days. A slight color change during storage is normal. [see Dosage and Administration (2.7)].
Administration Instructions
Advise patients or caregivers that when dosing a child with amoxicillin and clavulanate potassium for oral suspension, they should use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use [see Dosage and Administration (2.7)].
Allergic Reactions
Counsel patients that amoxicillin and clavulanate potassium for oral suspension contains a penicillin class drug product that can cause allergic reactions in some individuals [see Warnings and Precautions (5.1, 5.3)].
Severe Cutaneous Adverse Reactions (SCAR)
Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin and clavulanate potassium for oral suspension immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.2)].
Diarrhea
Counsel patients that diarrhea is a common problem caused by antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible. If diarrhea develops and is severe or lasts more than 2 or 3 days, advise the patients to call their doctor [see Warnings and Precautions (5.5)].
Risks in Patients with Phenylketonuria
Counsel patients with phenylketonuria that certain amoxicillin and clavulanate potassium for oral suspension contain aspartame, a source of phenylalanine [see Warnings and Precautions (5.8)]:
Antibacterial Resistance
Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, should only be used to treat bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium for oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium for oral suspension or other antibacterial drugs in the future [see Warnings and Precautions (5.9)].
Storage Instructions
Advise patients to keep amoxicillin and clavulanate potassium for oral suspension refrigerated and to shake well before using. Bottles of amoxicillin and clavulanate potassium for oral suspension may contain more liquid than required. Advise patients to follow their doctor’s instructions about the amount to use and the days of treatment required. Discard any unused medicine [see Dosage and Administration (2.7), How Supplied/Storage and Handling (16)].
The brands listed are trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 09/2026
NDC 65862-535-02
Rx only
Amoxicillin and
Clavulanate Potassium for
Oral Suspension, USP
600 mg/42.9 mg* per 5 mL
200 mL when reconstituted
AUROBINDO
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
| ebb3e917-326a-9e18-0354-a19c9f63a2f3 | Product name | 1 | 20140508 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-535-02 | ML - Milliliter | 65862-535 | 147baf52-d412-4dc9-97c5-af638eab6b2a | 1 | 2012-07-24 |
| 65862-535-13 | ML - Milliliter | 65862-535 | eca6d1cd-6ee2-4919-ac4f-59d813457c26 | 1 | 2012-07-24 |
| 65862-535-75 | ML - Milliliter | 65862-535 | 2fb1e45e-c1c8-4cdd-8609-24163ef0ff90 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | 3 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | 3 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | 3 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | 3 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | 3 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65862-535 | 65862-535-75, 65862-535-13, 65862-535-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AMOXICILLIN | 804826J2HU | ACTIM |
| CLAVULANATE POTASSIUM | Q42OMW3AT8 | ACTIM |
| ASPARTAME | Z0H242BBR1 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE 2910 (50 MPA.S) | 1IVH67816N | IACT |
| STRAWBERRY | 4J2TY8Y81V | IACT |
| SUCCINIC ACID | AB6MNQ6J6L | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 15 | 2025-02-11 | full-release | 2026-05-31 21:26:26 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | POWDER, FOR SUSPENSION / ORAL | 5 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | POWDER, FOR SUSPENSION / ORAL | 5 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| STRAWBERRY | STRAWBERRY | 4J2TY8Y81V | POWDER, FOR SUSPENSION / ORAL | 20 mg/5ml | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | POWDER, FOR SUSPENSION / ORAL | 5 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| STRAWBERRY | STRAWBERRY | 4J2TY8Y81V | POWDER, FOR SUSPENSION / ORAL | 20 mg/5ml | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | POWDER, FOR SUSPENSION / ORAL | 5 mg | ||
| STRAWBERRY | STRAWBERRY | 4J2TY8Y81V | POWDER, FOR SUSPENSION / ORAL | 20 mg/5ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| STRAWBERRY | STRAWBERRY | 4J2TY8Y81V | POWDER, FOR SUSPENSION / ORAL | 20 mg/5ml | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 |
| Application-product | TE code |
|---|---|
| A201091-001 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201091-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 3a93d1ddd44b… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A201091-001 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A201091-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A201091-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A201091-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201091-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201091-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201091-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201091-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201091-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201091-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201091-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201091-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201091-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201091-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201091-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201091-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201091-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201091-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A201091-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A201091-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A201091-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A201091-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A201091-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201091-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A201091-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201091-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201091-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201091-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201091-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201091-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201091-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A201091-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A201091-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201091-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201091-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201091-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201091-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A201091-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A201091-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201091-001 | AB | 1 | 3a93d1ddd44b… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3d50990e-9d7e-4a23-a135-97d5612ec0bc | 5200ae31-8a79-45f9-84fc-98f8448483a7 | 2025-02-11 | Warnings, Adverse reactions | 5200ae31-8a79-45f9-84fc-98f8448483a7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.