Label: CVS HEALTH NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

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

Drug Label Information

Updated August 21, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease

    Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers or any other sleep- aid.

    When using this product

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning:

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    • take only one dose per day (24 hours) – see Overdose warning
    • measure with dosing cup provided

    adults & children 12yrs & over

    One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

    Children under 12 yrs

    Do not use
  • Other information

    • each 30 mL dose contains: potassium 5 mg; sodium 10 mg
    • store at room temperature
    • protect from light. Does not meet USP <671>.
  • Inactive ingredients

    anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    CVS Health™

    NDC 59779-893-06

    Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid*

    Alcohol Free
    Nighttime

    Sleep-Aid

    DIPHENHYDRAMINE HCl

    Non-habit forming

    • Not for treating cold or flu

    Berry Flavor

    Naturally and Artificially Flavored

    6 FL OZ (177 mL)

    FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES.

    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 ZzzQuil®

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2019CVS/pharmacy

    CVS.com ®1-800-SHOP CVS

    V-30486

    CVS® Quality

    Money Back Guarantee

    CVS Health Nighttime Sleep-Aid Berry Flavor 6 FL OZ
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH NIGHTTIME SLEEP-AID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-893
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 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)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-893-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/22/2015
    Labeler - CVS Pharmacy,Inc. (062312574)
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