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

  • 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 October 13, 2014

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  • Active ingredients (in each 5 mL, 1 teaspoon)

    Brompheniramine maleate, USP 1 mg

    Phenylephrine HCl, USP 2.5 mg

  • Purpose

    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
    • 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 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

    If pregnant or breast-feeding,

     ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • do not take more than 6 doses in a 24-hour period 
    • use enclosed dosage cup
    • tsp = teaspoon, mL = milliliter
     age dose
    adults and children 12 years and over4 teaspoons (20 mL) every 4 hours
     children 6 to under 12 years 2 teaspoons (10 mL) every 4 hours
     children under 6 yearsdo not use
  • Other information

    • each teaspoon contains: sodium 3 mg
    • store at room temperature
  • Inactive ingredients

    blue #1, citric acid, flavor, glycerin, propylene glycol, purified water, red 40, sodium benzoate, sodium citrate, sorbitol, sucralose

  • Principal Display Panel

    Children's Cold & Allergy Elixir

    RELIEVES:

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

    Brompheniramine Maleate - Antihistamine

    Phenylephrine HCl - Nasal Decongestant

    *Compare to the Active Ingredients of DIMETAPP® Elixir

    Grape Flavor

    Alcohol Free 

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Dimetapp®.

    DISTRIBUTED BY: SELECT BRAND® DISTRIBUTORS

    Pine Bluff, AR 71603 USA

    AC (870) 535-3635

    MADE IN THE USA

  • Package Label

    Brompheniramine maleate 1 mg, Phenylephrine HCl 2.5 mg

    Select Brand Children's Cold & Allergy Grape Elixir

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND ALLERGY 
    brompheniramine maleate, phenylephrine hcl elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-954
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 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)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-954-041 in 1 BOX
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/11/2011
    Labeler - Select Brand Dist. (012578514)
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