CHILDRENS COLD AND ALLERGY RELIEF (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [SAFEWAY, INC.]

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CHILDRENS COLD AND ALLERGY RELIEF (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [SAFEWAY, INC.]
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NDC 21130-312-04
Set ID 707db423-d87d-47b9-b859-77e21b0a3d7a
Category HUMAN OTC DRUG LABEL
Packager Safeway, Inc.
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 2 mg

    Phenylephrine HCl 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
    • 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
    • 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

    • nervousness, dizziness or sleeplessness occur
    • 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 (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period 
    • measure only with dosing cup provided. Do not use any other dosing device. 
    • keep dosing cup with product 
    • mL=milliliter
    • shake well before using
     age dose
    adults and children 12 years and over20 mL every 4 hours
     children 6 to 11 years 10 mL every 4 hours
     children under 6 yearsdo not use
  • Other information

    • each 10 mL contains: sodium 5 mg
    • store between 20-25°C (68-77°F). Do not refrigerate. 
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

  • Principal Display Panel

    FOR AGES 6 YEARS & OVER

    Children's Cold & Allergy Relief

    Brompheniramine Maleate 2 mg

    -Antihistamine

    Phenylephrine HCl 5 mg

    -Nasal Decongestant

    Grape Flavor

    FL OZ (mL)

    Compare to Children's Dimetapp® Cold & Allergy active ingredients*

    • Relief of: Runny & stuffy nose,sneezing itchy, watery eyes & itching of the nose or throat
    • alcohol free
    • Dosing cup included  

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

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

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC.

    P.O BOX 99, PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

  • Package Label

    Brompheniramine Maleate 2 mg Phenylephrine HCI 5 mg

    Signature Care Children's Cold & Allergy Relief Grape Liquid

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND ALLERGY RELIEF 
    brompheniramine maleate, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-312
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-312-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201412/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/201412/30/2021
    Labeler - Safeway, Inc. (009137209)
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