Label: DYE FREE WAL SLEEP Z- 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 December 28, 2021

If you are a consumer or patient please visit this version.

  • 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

    Walgreens

    Compare to Vicks® ZzzQuil® Nighttime Sleep-Aid active ingredient ††

    NDC 0363-0753-12

    Dye –Free

    Wal-Sleep Z®

    Diphenhydramine HCl / Nighttime Sleep Aid

    DYE FREE

    SUGAR FREE

    Non – habit forming

    BERRY FLAVOR

    12 FL OZ (354 mL)

    NOT FOR TREATING COLD OR FLU,SEE WARNINGS.

    FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

    Walgreens Pharmacist Recommended

    Walgreens Pharmacist Survey

    †† This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMONT RD, DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    Walgreens.com ©2018 Walgreen Co.

    Walgreens Dye Free Wal- Sleep Z Berry Flavor 12 FL OZ
  • INGREDIENTS AND APPEARANCE
    DYE FREE WAL SLEEP Z 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0753
    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:0363-0753-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/24/2018
    Labeler - WALGREEN CO. (008965063)