Label: CHILDRENS COLD AND ALLERGY- phenylephrine hcl, brompheniramine maleate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 May 10, 2016

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

  • Active ingredients (in each 10 mL)

    Brompheniramine maleate, USP 2 mg

    Phenylephrine HCl, USP 5 mg

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  • Purposes

    Antihistamine

    Nasal decongestant

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  • Uses

    temporarily relieves 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
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  • Warnings

    Do not use

    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.
    to make a child sleepy

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    glaucoma
    trouble urinating due to an enlarged prostate gland
    a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    do not use more than directed
    drowsiness may occur
    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

    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 (1-800-222-1222).

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  • 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

    age

    dose

    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

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  • Other information

    each 10 mL contains: sodium 4 mg
    store at 20-25°C (68-77°F)
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  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredients in Dimetapp® Cold & Allergy

    Grape Flavor

    Children’s

    Cold & Allergy

    BROMPHENIRAMINE MALEATE

    Antihistamine

    PHENYLEPHRINE HCl

    Nasal decongestant

    Liquid

    Relieves:

    Nasal congestion; Stuffy nose; Runny nose; Sneezes; Itchy, watery eyes; Itchy nose & throat

    Alcohol free

    Grape Flavor

    For Ages 6 Years & Over

    4 FL OZ (118 mL)

    CVS Health Children's Cold & Allergy
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND ALLERGY 
    phenylephrine hcl, brompheniramine maleate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-698
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 10 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color PURPLE (clear bluish-red) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-698-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/24/2006
    Labeler - CVS Pharmacy (062312574)
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