Label: CVS HEALTH NIGHTTIME SLEEP AID- diphenhydramine hydrochloride liquid

  • 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 October 18, 2017

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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

    Ask a doctor before use if you have

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

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

    When using this product

    •
    avoid alcoholic beverages

    Stop use and ask a doctor if sleeplessness 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.

    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)
    •
    Measure with dosing cup provided
     
    adults & children 12 yrs & over
     
    One Dose = 30 mL 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: sodium 23 mg
    •
    store at room temperature
    •
    protect from light. Does not meet USP requirements for light-resistant packaging
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    CVS Health™

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

    NDC 69842-753-12

    Alcohol Free

    Nighttime

    Sleep-Aid

    Diphenhydramine HCl, 50 mg

    Non – habit forming

    DYE FREE

    BERRY FLAVOR

    12 FL OZ (354 mL)

    SEE NEW WARNINGS.

    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™ Nighttime Sleep-Aid.

    DISTRIBUTED BY: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2018 CVS/ Pharmacy

    CVS .com® 1-800-SHOP CVS

    CVS Quality Money Back Guarantee

    CVS Health Nighttime Sleep-Aid Diphenhydramine HCl 50 mg 12 FL OZ
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-753
    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)  
    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
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-753-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/11/2017
    Labeler - CVS Pharmacy,Inc. (062312574)
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