Indications and uses
temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more t...
• each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing
Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
liver disease
taking the blood thinning drug warfarin
do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Weight (lb) | Age (yr) | Dose (mL)* |
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL |
36-47 | 4-5 years | 7.5 mL |
48-59 | 6-8 years | 10 mL |
60-71 | 9-10 years | 12.5 mL |
72-95 | 11 years | 15 mL |
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
anhydrous citric acid, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
1-800-719-9260
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | 3 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 3 | |
| CARRAGEENAN | INACTIVE INGREDIENT | 5C69YCD2YJ | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 3 | |
| SODIUM PHOSPHATE, TRIBASIC | INACTIVE INGREDIENT | A752Q30A6X | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-0971 | 0363-0971-26, 0363-0971-28, 0363-0971-34 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | PASTE / DENTAL | 249 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | CAPSULE / ORAL | 160 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION, EXTENDED RELEASE / ORAL | 62 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION, CONCENTRATE / INTRAVENOUS | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, COATED / ORAL | 3.2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / SOFT TISSUE | 15 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| CALCIUM SULFATE | CALCIUM SULFATE | WAT0DDB505 | TABLET / ORAL | 2734 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w |
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 |
|---|---|---|---|---|---|---|
| e7c65773-7fd1-4dd9-bbf9-cd7f9a737a36 | 874c8c30-5cf5-4c1a-b1af-ca64af2e6a5a | 2024-10-21 | Warnings | 874c8c30-5cf5-4c1a-b1af-ca64af2e6a5a |
Adverse event summaries are temporarily unavailable. Other product information remains available.