CARBAMAZEPINE suspension

Carbamazepine by

Drug Labeling and Warnings

Carbamazepine by is a Prescription medication manufactured, distributed, or labeled by Precision Dose, Inc., Morton Grove Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Agents That May Affect Carbamazepine Plasma Levels

When carbamazepine is given with drugs that can increase or decrease carbamazepine levels, close monitoring of carbamazepine levels is indicated and dosage adjustment may be required.

Agents That Increase Carbamazepine Levels

CYP 3A4 inhibitors inhibit carbamazepine oral suspension metabolism and can thus increase plasma carbamazepine levels. Drugs that have been shown, or would be expected, to increase plasma carbamazepine levels include:

aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, trazodone, olanzapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles (e.g., ketaconazole, itraconazole, fluconazole, voriconazole), acetazolamide, verapamil, ticlopidine, grapefruit juice, and protease inhibitors.

Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,11-transdiol derivative from carbamazepine-10,11 epoxide. Co-administration of inhibitors of human microsomal epoxide hydrolase may result in increased carbamazepine-10,11 epoxide plasma concentrations.

Accordingly, the dosage of carbamazepine should be adjusted and/or the plasma levels monitored when used concomitantly with loxapine, quetiapine, or valproic acid.

Agents That Decrease Carbamazepine Levels

CYP3A4 inducers can increase the rate of carbamazepine metabolism. Drugs that have been shown, or that would be expected, to decrease plasma carbamazepine levels include:

cisplatin, doxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.

Effect of Carbamazepine on Plasma Levels of Concomitant Agents

Decreased Levels of Concomitant Medications

Carbamazepine is a potent inducer of hepatic 3A4 and is also known to be an inducer of CYP1A2, 2B6, 2C9/19 and may therefore reduce plasma concentrations of co-medications mainly metabolized by CYP 1A2, 2B6, 2C9/19 and 3A4, through induction of their metabolism. When used concomitantly with Carbamazepine, monitoring of concentrations or dosage adjustment of these agents may be necessary:

  • When carbamazepine is added to aripiprazole, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. If carbamazepine is later withdrawn, the aripiprazole dose should be reduced.
  • When carbamazepine is used with tacrolimus, monitoring of tacrolimus blood concentrations and appropriate dosage adjustments are recommended.
  • The use of concomitant strong CYP3A4 inducers such as carbamazepine should be avoided with temsirolimus. If patients must be coadministered carbamazepine with temsirolimus, an adjustment of temsirolimus dosage should be considered.
  • The use of carbamazepine with lapatinib should generally be avoided. If carbamazepine is started in a patient already taking lapatinib, the dose of lapatinib should be gradually titrated up. If carbamazepine is discontinued, the lapatinib dose should be reduced.
  • Concomitant use of carbamazepine with nefazodone results in plasma concentrations of nefazodone and its active metabolite insufficient to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated (see CONTRAINDICATIONS).
  • Monitor concentrations of valproate when carbamazepine is introduced or withdrawn in patients using valproic acid.

In addition, carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sertraline, sirolimus, tadalafil, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide.

Other Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carbamazepine, when administered to Sprague-Dawley rats for two years in the diet at doses of 25, 75, and 250 mg/kg/day, resulted in a dose-related increase in the incidence of hepatocellular tumors in females and of benign interstitial cell adenomas in the testes of males.

Carbamazepine must, therefore, be considered to be carcinogenic in Sprague-Dawley rats. Bacterial and mammalian mutagenicity studies using carbamazepine produced negative results. The significance of these findings relative to the use of carbamazepine in humans is, at present, unknown.

Usage in Pregnancy

Pregnancy Category D (see WARNINGS).

Labor and Delivery

The effect of carbamazepine on human labor and delivery is unknown.

Nursing Mothers

Carbamazepine and its epoxide metabolite are transferred to breast milk. The ratio of the concentration in breast milk to that in maternal plasma is about 0.4 for carbamazepine and about 0.5 for the epoxide. The estimated doses given to the newborn during breast-feeding are in the range of 2 to 5 mg daily for carbamazepine and 1 to 2 mg daily for the epoxide.

Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Substantial evidence of carbamazepine's effectiveness for use in the management of children with epilepsy (see INDICATIONS AND USAGE for specific seizure types) is derived from clinical investigations performed in adults and from studies in several in vitro systems which support the conclusion that (1) the pathogenetic mechanisms underlying seizure propagation are essentially identical in adults and children, and (2) the mechanism of action of carbamazepine in treating seizures is essentially identical in adults and children.

Taken as a whole, this information supports a conclusion that the generally accepted therapeutic range of total carbamazepine in plasma (i.e., 4 to 12 mcg/mL) is the same in children and adults.

The evidence assembled was primarily obtained from short-term use of carbamazepine. The safety of carbamazepine in children has been systematically studied up to 6 months. No longer-term data from clinical trials is available.

Geriatric Use

No systematic studies in geriatric patients have been conducted.

  • ADVERSE REACTIONS

    If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.

    The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver, and the cardiovascular system.

    The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.

    The following additional adverse reactions have been reported:

    Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute, intermittent porphyria, variegate porphyria, porphyria cutanea tarda.

    Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis and hirsutism. In certain cases, discontinuation of therapy may be necessary.

    Cardiovascular System: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e.g. pulmonary embolism), and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

    Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis; very rare cases of hepatic failure.

    Pancreatic: Pancreatitis.

    Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.

    Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been very rare reports of impaired male fertility and/or abnormal spermatogenesis.

    Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day.

    Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown.

    Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis and neuroleptic malignant syndrome.

    There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established.

    Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of psychotropic drugs.

    Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis.

    Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure (see WARNINGS, General) as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes.

    Musculoskeletal System: Aching joints and muscles, and leg cramps.

    Metabolism: Fever and chills. Hyponatremia (see WARNINGS,General). Decreased levels of plasma calcium have been reported. Osteoporosis has been reported.

    Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.

    A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

  • DRUG ABUSE AND DEPENDENCE

    No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

  • OVERDOSAGE

    Acute Toxicity

    Lowest known lethal dose: adults, 3.2 g (a 24-year-old woman died of a cardiac arrest and a 24-year-old man died of pneumonia and hypoxic encephalopathy); children, 4 g (a 14-year-old girl died of a cardiac arrest), 1.6 g (a 3-year-old girl died of aspiration pneumonia).

    Oral LD50 in animals (mg/kg): mice, 1100 to 3750; rats, 3850 to 4025; rabbits, 1500 to 2680; guinea pigs, 920.

    Signs and Symptoms

    The first signs and symptoms appear after 1 to 3 hours. Neuromuscular disturbances are the most prominent. Cardiovascular disorders are generally milder, and severe cardiac complications occur only when very high doses (greater than 60 g) have been ingested.

    Respiration: Irregular breathing, respiratory depression.

    Cardiovascular System: Tachycardia, hypotension or hypertension, shock, conduction disorders.

    Nervous System and Muscles: Impairment of consciousness ranging in severity to deep coma. Convulsions, especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos, ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances, dysmetria. Initial hyperreflexia, followed by hyporeflexia.

    Gastrointestinal Tract: Nausea, vomiting.

    Kidneys and Bladder: Anuria or oliguria, urinary retention.

    Laboratory Findings: Isolated instances of overdosage have included leukocytosis, reduced leukocyte count, glycosuria, and acetonuria. EEG may show dysrhythmias.

    Combined Poisoning: When alcohol, tricyclic antidepressants, barbiturates, or hydantoins are taken at the same time, the signs and symptoms of acute poisoning with carbamazepine may be aggravated or modified.

    Treatment

    The prognosis in cases of severe poisoning is critically dependent upon prompt elimination of the drug, which may be achieved by inducing vomiting, irrigating the stomach, and by taking appropriate steps to diminish absorption. If these measures cannot be implemented without risk on the spot, the patient should be transferred at once to a hospital, while ensuring that vital functions are safeguarded. There is no specific antidote.

    Elimination of the Drug: Induction of vomiting. Gastric lavage. Even when more than 4 hours have elapsed following ingestion of the drug, the stomach should be repeatedly irrigated, especially if the patient has also consumed alcohol.

    Measures to Reduce Absorption: Activated charcoal, laxatives.

    Measures to Accelerate Elimination: Forced diuresis. Dialysis is indicated only in severe poisoning associated with renal failure. Replacement transfusion is indicated in severe poisoning in small children.

    Respiratory Depression: Keep the airways free; resort, if necessary, to endotracheal intubation, artificial respiration, and administration of oxygen.

    Hypotension, Shock: Keep the patient's legs raised and administer a plasma expander. If blood pressure fails to rise despite measures taken to increase plasma volume, use of vasoactive substances should be considered.

    Convulsions: Diazepam or barbiturates.

    Warning: Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension, and coma. However, barbiturates should not be used if drugs that inhibit monoamine oxidase have also been taken by the patient either in overdosage or in recent therapy (within 1 week).

    Surveillance: Respiration, cardiac function (ECG monitoring), blood pressure, body temperature, pupillary reflexes, and kidney and bladder function should be monitored for several days.

    Treatment of Blood Count Abnormalities: If evidence of significant bone marrow depression develops, the following recommendations are suggested: (1) stop the drug, (2) perform daily CBC, platelet, and reticulocyte counts, (3) do a bone marrow aspiration and trephine biopsy immediately and repeat with sufficient frequency to monitor recovery.

    Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) 59Fe-ferrokinetic studies, (3) peripheral blood cell typing, (4) cytogenetic studies on marrow and peripheral blood, (5) bone marrow culture studies for colony-forming units, (6) hemoglobin electrophoresis for A2 and F hemoglobin, and (7) serum folic acid and B12 levels.

    A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought.

  • DOSAGE AND ADMINISTRATION

    (see table below):

    Carbamazepine oral suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions). Because the extent to which this occurs with other liquid medications is not known, carbamazepine oral suspension should not be administered simultaneously with other liquid medications or diluents. Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals.

    Since a given dose of carbamazepine oral suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: 1/2 teaspoonful q.i.d.) and to increase slowly to avoid unwanted side effects.

    Conversion of patients from oral carbamazepine tablets to carbamazepine oral suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).

    Epilepsy

    (see INDICATIONS AND USAGE)

    Adults and children over 12 years of age - Initial

    1 teaspoonful q.i.d. of the suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a t.i.d. or q.i.d. regimen of the suspension until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances.

    Maintenance

    Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

    Children 6 to 12 years of age - Initial

    1/2 teaspoonful q.i.d. of the suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen of the suspension until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily.

    Maintenance

    Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

    Children under 6 years of age - Initial

    10 to 20 mg/kg/day q.i.d. of the suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

    Combination Therapy

    Carbamazepine oral suspension may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Pregnancy Category D).

    Trigeminal Neuralgia

    (see INDICATIONS AND USAGE)

    Initial

    On the first day, 1/2 teaspoonful q.i.d. of the suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 50 mg (1/2 teaspoonful) q.i.d. of the suspension, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily.

    Maintenance

    Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

  • Dosage Information

    Initial DoseSubsequent DoseMaximum Daily Dose
    IndicationSuspensionSuspensionSuspension
    Epilepsy
    Under 6 yr
    10 to 20 mg/kg/day q.i.d.Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d.35 mg/kg/24 hr (see Dosage and Administration section above)
    6–12 yr1/2 tsp q.i.d. (200 mg/day)Add up to 1 tsp (100 mg)/day at weekly intervals, t.i.d. or q.i.d.1000 mg/24 hr
    Over 12 yr1 tsp q.i.d. (400 mg/day)Add up to 2 tsp (200 mg)/day at weekly intervals, t.i.d. or q.i.d.1000 mg/24 hr (12–15 yr)
    1200 mg/24 hr (>15 yr)
    1600 mg/24 hr (adults, in rare instances)
    Trigeminal Neuralgia1/2 tsp q.i.d. (200 mg/day)Add up to 2 tsp (200 mg)/day in increments of 50 mg (1/2 tsp) q.i.d.1200 mg/24 hr
  • HOW SUPPLIED

    Carbamazepine Oral Suspension, USP 100 mg/5 mL (teaspoonful) is a yellow-orange, citrus-vanilla flavored suspension, supplied as follows:

    NDC: 68094-007-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC: 68094-008-62
    10 mL per unit dose cup
    Thirty (30) cups per shipper

    Shake well before using.

    Store at 20 °–25 °C (68 °–77 °F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Manufactured By:
    Morton Grove Pharmaceuticals, Inc.
    Morton Grove, IL 60053

    Manufactured For:
    Wockhardt USA, LLC
    Parsippany, NJ 07054

    Packaged By:
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI1068 Rev. 07/16

  • MEDICATION GUIDE

    Carbamazepine Oral Suspension,
    USP
    100 mg/5 mL
    (Carbamazepine)

    Read this Medication Guide before you start taking Carbamazepine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

    What is the most important information I should know about Carbamazepine?

    Do not stop taking Carbamazepine without first talking to your healthcare provider.

    Stopping Carbamazepine suddenly can cause serious problems.

    Carbamazepine can cause serious side effects, including:

    How can I watch for early symptoms of suicidal thoughts and actions?

    Do not stop Carbamazepine without first talking to a healthcare provider.

    Stopping Carbamazepine suddenly can cause serious problems. You should talk to your healthcare provider before stopping.

    Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

    What is Carbamazepine?

    Carbamazepine is a prescription medicine used to treat:

    Who should not take Carbamazepine?

    Do not take Carbamazepine if you:

    What should I tell my healthcare provider before taking Carbamazepine?

    Before you take Carbamazepine, tell your healthcare provider if you:

    Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

    Taking Carbamazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

    Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

    How should I take Carbamazepine?

    What should I avoid while taking Carbamazepine?

    What are the possible side effects of Carbamazepine?

    See "What is the most important information I should know about Carbamazepine?"

    Carbamazepine may cause other serious side effects. These include:

    Get medical help right away if you have any of the symptoms listed above or listed in "What is the most important information I should know about Carbamazepine".

    The most common side effects of Carbamazepine include:

    These are not all the possible side effects of Carbamazepine. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store Carbamazepine Oral Suspension?

    Keep Carbamazepine and all medicines out of the reach of children.

    General Information about Carbamazepine

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Carbamazepine for a condition for which it was not prescribed. Do not give Carbamazepine to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about Carbamazepine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about Carbamazepine that is written for health professionals.

    For more information, go to www.wockhardtusa.com or call 1-800-346-6845.

    What are the ingredients in Carbamazepine?

    Active ingredient: carbamazepine

    Inactive ingredients:

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured By:
    Morton Grove Pharmaceuticals, Inc.
    Morton Grove, IL 60053

    Manufactured For:
    Wockhardt USA, LLC
    Parsippany, NJ 07054

    Packaged By:
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI1068 Rev. 07/16

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    NDC: 68094-007-59
    PrecisionDose™

    carBAMazepine
    Oral Suspension, USP
    100 mg/5 mL

    Pkg: Precision Dose, Inc., S. Beloit, IL 61080

    Principal Display Panel - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

    NDC: 68094-008-59
    PrecisionDose

    CARBAMAZEPINE
    Oral Suspension, USP
    200 mg/10 mL

    Delivers 10 mL
    Shake Well
    Rx Only

    Store at 20° to 25°C (68° to 77°F)
    Pkg. By: Precision Dose, Inc.
    S. Beloit, IL 61080
    1066 R0

    Principal Display Panel - 10 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    CARBAMAZEPINE 
    carbamazepine suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68094-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M) Carbamazepine100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    sucrose (UNII: C151H8M554)  
    sorbitol (UNII: 506T60A25R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    xanthan gum (UNII: TTV12P4NEE)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    vanillin (UNII: CHI530446X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    Water (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorYELLOW, ORANGEScore    
    ShapeSize
    FlavorCITRUS, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68094-007-623 in 1 CASE10/04/2017
    110 in 1 TRAY
    1NDC: 68094-007-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07571410/04/2017
    CARBAMAZEPINE 
    carbamazepine suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68094-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M) Carbamazepine200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    sucrose (UNII: C151H8M554)  
    sorbitol (UNII: 506T60A25R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    xanthan gum (UNII: TTV12P4NEE)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    vanillin (UNII: CHI530446X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    Water (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorYELLOW, ORANGEScore    
    ShapeSize
    FlavorCITRUS, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68094-008-623 in 1 CASE10/04/2017
    110 in 1 TRAY
    1NDC: 68094-008-5910 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07571410/04/2017
    Labeler - Precision Dose, Inc. (035886746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morton Grove Pharmaceuticals, Inc.801897505MANUFACTURE(68094-007, 68094-008)

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