Label: CHILDRENS DIMETAPP COLD AND COUGH- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 19, 2020

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  • ACTIVE INGREDIENTS (IN EACH 10 ML)

    Brompheniramine maleate, USP 2 mg

    Dextromethorphan HBr, USP 10 mg

    Phenylephrine HCl , USP 5 mg

  • PURPOSES

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • USES

    •
    temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    •
    temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    •
    runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat
    •
    temporarily restores freer breathing through the nose
  • WARNINGS

    Do not use

    •
    to sedate a child or to make a child sleepy
    •
    if you are 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.

    Ask a doctor before use if you have

    •
    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 persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

    •
    taking any other oral nasal decongestant or stimulant
    •
    taking sedatives or tranquilizers

    When using this product

    •
    do not use more than directed
    •
    may cause marked drowsiness
    •
    avoid alcoholic beverages
    •
    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

    •
    you get nervous, dizzy, or sleepless
    •
    symptoms do not get better within 7 days or are accompanied by fever
    •
    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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.

  • DIRECTIONS

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosage cup provided
    •
    keep dosage cup with product
    •
    ml = milliliter
    agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children 6 to under 12 years

    10 ml every 4 hours

    children under 6 years

    do not use
  • OTHER INFORMATION

    •
    each 10 ml contains: sodium 6 mg
    •
    store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENTS

    anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • QUESTIONS OR COMMENTS?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 0031-2234-13

    Children's
    Dimetapp®

    BROMPHENIRAMINE MALEATE (Antihistamine)
    DEXTROMETHORPHAN HBr (Cough Suppressant)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    Cold
    & Cough

    Relieves Nasal Symptoms

    ✓ Stuffy Nose
    ✓ Runny Nose
    ✓ Sneezing

    Plus Other Symptoms

    ✓ Itchy, Watery Eyes
    ✓ Cough

    For Ages
    6 Yrs.
    & Over

    4 FL OZ (118 ml) alcohol-free • grape flavor

    Principal Display Panel - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS DIMETAPP COLD AND COUGH 
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLE (purple liquid) Score    
    ShapeSize
    FlavorGRAPE (grape flavor and odor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2234-131 in 1 CARTON05/23/2006
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0031-2234-191 in 1 CARTON05/23/2006
    2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/23/2006
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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