Label: CHILDRENS COUGH AND COLD- chlorpheniramine maleate, dextrometrorphan hbr liquid

  • NDC Code(s): 55319-754-04
  • Packager: FAMILY DOLLAR SERVICES INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 4, 2024

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  • DRUG FACTS

  • Active ingredients (in each 10 mL)

    Chlorpheniramine maleate, USP 2 mg

    Dextromethorphan HBr, USP 15 mg

  • Purposes

    Antihistamine

    Cough suppressant

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • 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

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • 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

    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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

    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 4 doses in any 24-hour period
    agedose

    Children under 6 years

    do not use

    children 6 to under 12 years

    10 mL every 6 hours

    adults and children 12 years and older

    20 mL every 6 hours

    Other information

    • each 10 mL contains: sodium 7 mg
    • store at room temperature. Do not refrigerate.
  • Inactive ingredients

    Anhydrous citric acid, FD&C red no. 40, Glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • QUESTIONS OR COMMENTS?

    1-866-467-2748

  • Prinipal Display of Packaging

    Compare to the active ingredients in Children’s Robitussin ®Cough & Cold Long–Acting*

    NDC 55319-754-04

    CHILDREN’S

    COUGH & COLD

    Chlorpheniramine Maleate USP 2 mg (Antihistamine)

    Dextromethorphan HBr, USP 15 mg (Cough Suppressant)

    Long-Acting

    Relieves:

    • Cough up to 8 hours
    • Runny nose
    • No Added alcohol
    • For Ages 6 & Over

    Fruit Punch Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling

    Distributed by:

    Family Dollar childrens Cough & Cold 4 FL OZ Fruit Punch Flavor
  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH AND COLD 
    chlorpheniramine maleate, dextrometrorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-754
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-754-041 in 1 CARTON05/08/2023
    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 DrugM01205/08/2023
    Labeler - FAMILY DOLLAR SERVICES INC (024472631)
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