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
  • 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 September 16, 2023

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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 finalpart34105/08/2023
    Labeler - FAMILY DOLLAR SERVICES INC (024472631)
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