COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-775-04
Set ID 71535b7b-01df-4a02-9e1d-917544bd51ce
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (Chain Drug Marketing Association)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 10 mL)

    Brompheniramine Maleate 2 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and 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
    • thyroid disease
    • diabetes
    • glaucoma
    • high blood pressure  ​​
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    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
    • marked 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 improve within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.These could be a sign of a serious condition

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: 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
    Age Dose
     adults and children 12 years and over 20 mL every 4 hours
     children 6 to 11 years 10 mL every 4 hours
     children under 6 years do not use

  • Other information

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

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

  • Principal Display Panel

    *Compare to the active ingredients in Children's Dimetapp® Cold & Cough

    Children's Dibromm

    Cold & Cough

    Brompheniramine Maleate Anthihistamine

    Dextromethorphan HBr Cough Suppressant

    Phenylephrine HCl Nasal Decongestant

    For Ages 6 & Over

    Alcohol Free

    Grape Flavor

    FL OZ (mL)

    Dosing Cup Included

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR 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 & Cough.

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Question: 248-449-9300

  • Product Label

    Brompheniramine Maleate 2 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg

    QUALITY CHOICE Children's Dibromm Cold & Cough

  • INGREDIENTS AND APPEARANCE
    COLD AND COUGH  CHILDRENS
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-775
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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)  
    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:63868-775-041 in 1 BOX09/30/2015
    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 FINALpart34109/30/2015
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

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