Label: CVS NIGHTTIME CHILDRENS COLD AND COUGH MULTI-SYMPTOM RELIEF- chlorpheniramine maleate and dextromethorphan hydrobromide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 15 mL)     		Purpose

    Chlorpheniramine maleate 2 mg

    Antihistamine

    Dextromethorphan HBr 15 mg

    Cough suppressant
  • Uses

    temporarily relieves cold symptoms:

    ▪
    cough due to minor throat & bronchial irritation
    ▪
    sneezing
    ▪
    runny nose
  • Warnings

    Do not use

    ▪
    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.
    ▪
    to make a child sleepy

    Ask a doctor before use if you have

    ▪
    glaucoma
    ▪
    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
    ▪
    trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    ▪
    excitability may occur, especially in children
    ▪
    marked drowsiness may occur
    ▪
    avoid alcoholic drinks
    ▪
    be careful when driving a motor vehicle or operating machinery
    ▪
    alcohol, sedatives, & tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    ▪
    cough persists more than 1 week, tends to recur 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

    ▪
    take only as directed
    ▪
    do not exceed 4 doses per 24 hrs.
    ▪
    only use the dose cup provided

    adults & children 12 yrs & over

    30 mL every 6 hrs.

    children 6 to under 12 yrs

    15 mL every 6 hrs.

    children 4 to under 6 yrs

    do not use unless directed by a doctor

    children under 4 yrs

    do not use
  • Other information

    ▪
    each 15 mL contains: potassium 5 mg, sodium 5 mg
    ▪
    sugar free
    ▪
    aspirin free
    ▪
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    Compare to the active ingredients in Children’s Vicks Nyquil™ Cold & Cough*

    NDC 51316-752-08

    Nighttime

    Childrens

    Cold & Cough

    Chlorpheniramine maleate 2 mg,

    Dextromethorphan HBr 15 mg

    •
    Sneezing
    •
    Runny Nose
    •
    Cough

    No Added Alcohol, Acetaminophen Free

    Berry Flavor

    Naturally and Artificially Flavored

    8 FL OZ (236 ml)

    DISTRIBUTED BY:

    TAMPER EVIDENT: Do not use if printed shrink band is missing or broken.

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks® Nyquil™ Cold & Cough.

    CVS Nighttime Children's cold and cough Berry Flavor
  • INGREDIENTS AND APPEARANCE
    CVS NIGHTTIME CHILDRENS  COLD AND COUGH MULTI-SYMPTOM RELIEF
    chlorpheniramine maleate and dextromethorphan hydrobromide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-752
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-752-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01002/20/2023
    Labeler - CVS PHARMACY (062312574)
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