CHILDRENS DIMETAPP MULTI-SYMPTOM COLD RELIEF DYE-FREE (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [RICHMOND DIVISION OF WYETH]

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  • CHILDRENS DIMETAPP MULTI-SYMPTOM COLD RELIEF DYE-FREE (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [RICHMOND DIVISION OF WYETH]

CHILDRENS DIMETAPP MULTI-SYMPTOM COLD RELIEF DYE-FREE (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [RICHMOND DIVISION OF WYETH]
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NDC 0031-2295-12
Set ID 569d2640-1a8c-4b68-8bd3-15b675d92ae5
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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, 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

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    NDC 0031-2295-12

    Children's
    Dimetapp®

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

    Multi-Symptom
    Cold Relief
    DYE-FREE

    Relieves Nasal Symptoms

    1.
    Stuffy Nose
    2.
    Runny Nose
    3.
    Sneezing

    Plus Other Symptoms

    1.
    Itchy, Watery Eyes
    2.
    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 MULTI-SYMPTOM COLD RELIEF DYE-FREE 
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2295
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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
    ColorYELLOW (colorless to pale yellow, clear liquid) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2295-121 in 1 CARTON06/01/201608/31/2022
    1118 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 finalpart34106/01/201608/31/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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