Label: CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  • NDC Code(s): 0031-2246-12
  • Packager: Richmond Division of Wyeth
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/10

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

    Acetaminophen, USP 160 mg

    Chlorpheniramine maleate, USP 1 mg

    Dextromethorphan HBr, USP 5 mg

    Phenylephrine HCl, USP 2.5 mg

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  • PURPOSES

    Pain reliever/Fever reducer

    Antihistamine

    Cough suppressant

    Nasal decongestant

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  • USES

    • temporarily relieves these symptoms associated with a cold, or flu:
      • headache
      • sore throat
      • fever
      • minor aches and pains
    • temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes
      • runny nose
    • temporarily restores freer breathing through the nose
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  • WARNINGS

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if user takes

    • more than 5 doses in any 24-hour period, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    Do not use

    • to sedate a child or to make a child sleepy
    • in a child under 6 years of age
    • if user is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

    Ask a doctor before use if user has

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if user is

    • taking the blood thinning drug warfarin
    • taking any other oral nasal decongestant or stimulant
    • taking any other pain reliever/fever reducer
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • user gets nervous, dizzy, or sleepless
    • pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

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  • DIRECTIONS

    • do not take more than 5 doses in any 24-hour period
    • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
    age dose
    adults and children 12 years and over 4 teaspoons every 4 hours
    children 6 to 12 years 2 teaspoons every 4 hours
    children under 6 years do not use
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  • OTHER INFORMATION

    • each teaspoon contains: sodium 2 mg
    • store at 20-25°C (68-77°F)
    • dosage cup provided
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  • INACTIVE INGREDIENTS

    anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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  • QUESTIONS OR COMMENTS?

    Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

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  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    SEE NEW WARNINGS INFORMATION

    Children’s Dimetapp Multi-Symptom Cold & Flu

    Acetaminophen (Pain Reliever/Fever Reducer)

    Chlorpheniramine Maleate (Antihistamine)

    Dextromethorphan HBr (Cough Suppressant)

    Phenylephrine HCl (Nasal Decongestant)

    Relieves Nasal Symptoms

    • Stuffy Nose
    • Runny Nose
    • Sneezing

    Plus Other Symptoms

    • Itchy, Watery Eyes
    • Cough
    • Fever, Headaches
    • Body Aches

    4 FL OZ (118 mL)

    alcohol-free ∙ red grape flavor

    For most recent product information, visit www.dimetapp.com

    We pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family.

    Dosage Cup Provided

    PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

    Pfizer

    Madison, NJ 07940 USA

    © 2010 Pfizer Inc.

    Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

    PAA018215.jpg
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0031-2246
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    acetaminophen (acetaminophen) acetaminophen 160 mg  in 5 mL
    chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate 1 mg  in 5 mL
    dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide 5 mg  in 5 mL
    phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    citric acid monohydrate  
    FD&C Red No. 40  
    glycerin  
    menthol  
    polyethylene glycol  
    propyl gallate  
    propylene glycol  
    water  
    sodium benzoate  
    sodium citrate  
    sorbitol  
    sucralose  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0031-2246-12 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 10/04/2010
    Labeler - Richmond Division of Wyeth (829390827)
    Establishment
    Name Address ID/FEI Business Operations
    Richmond Division of Wyeth 829390827 MANUFACTURE, ANALYSIS, LABEL, PACK
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