CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) ELIXIR [SELECT BRAND DIST.]

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CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) ELIXIR [SELECT BRAND DIST.]
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NDC 15127-954-04
Set ID 8fb7b5ad-4ba8-422a-9fc9-571de2c05873
Category HUMAN OTC DRUG LABEL
Packager Select Brand Dist.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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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