Label: SLEEP AID- diphenhydramine hcl solution

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

Drug Label Information

Updated March 8, 2024

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  • Active ingredient (in each 30 mL)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for 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 2 weeks. Insomnia may be a symptom of a 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.

  • Directions

    • do not take more than directed
    • mL = milliliter
    • only use the dose cup provided
    • take only one dose per day (24 hours)
    • adults and children 12 years and over: 30 mL at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each 30 mL contains: sodium 21 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

  • Questions or comments?

    1-888-287-1915

  • Principal display panel

    NDC 49035-704-02

    Equate™

    Compare to VICKS® ZzzQuil® Nighttime Sleep-Aid active ingredient*

    Nighttime
    Sleep-Aid

    Diphenhydramine HCl
    50 mg per 30 mL
    Nighttime Sleep-Aid

    • Non-habit forming
    • Not for colds or for pain
    •Ages 12+

    F-047
    ORG

    12 FL OZ (355 mL)

    Cherry
    Vanilla

    Satisfaction guaranteed – Or we’ll replace it or give you your money back. For questions or
    comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
    PRODUCT OF CHINA
    *This product is not manufactured or distributed by The Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil® Nighttime Sleep-Aid.

    50844 ORG052304702

    TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP
    IS BROKEN OR MISSING

    Equate 44-047

    Equate 44-047

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-704
    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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorred (Maroon) Score    
    ShapeSize
    FlavorCHERRY, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-704-02355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/18/2019
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(49035-704) , pack(49035-704)
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