Label: CVS CHILDRENS COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl 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 September 12, 2023

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  • DRUG FACTS

  • Active Ingredients (in each 10 mL)

    Brompheniramine maleate, USP 2 mg

    Phenylephrine HCl, USP 5 mg

  • PURPOSES

    Antihistamine

    Nasal Decongestant

  • 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
  • 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
    ▪
    a breathing problem such as emphysema, asthma, or chronic bronchitis

    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
    ▪
    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 at 1-800-222-1222.

  • 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 room temperature
  • INACTIVE INGREDIENTS

    anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy*

    NDC# 69842-639-04

    Children'sCold & Allergy

    Brompheniramine Maleate USP (Antihistamine)
    Phenylephrine HCl USP (Nasal Decongestant)

    •
    Stuffy Nose
    •
    Runny Nose
    •
    Sneezing
    •
    Itchy, Watery Eyes

    Alcohol-Free • Sugar Free

    Ages 6 Years and Over

    Grape Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 ml)

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2020 CVS/pharmacy

    CVS.com 1-800-SHOP CVS

    V12431

    CVS Quality

    Money Back Guaranteed

    *This product is not manufactured or distributed by Pfizer, the distributor of Children’s Dimetapp® Cold & Allergy.

    CVS Childrens Cold and Allergy Relief Dimetapp
  • INGREDIENTS AND APPEARANCE
    CVS CHILDRENS COLD AND ALLERGY 
    brompheniramine maleate, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-639
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-639-041 in 1 CARTON03/30/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Labeler - CVS PHARMACY, INC. (062312574)
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