CVS HEALTH NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]

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CVS HEALTH NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]
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NDC 69842-753-12
Set ID 03f521f4-d35f-4f66-b3ad-7e58a244eb93
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy,Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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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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