Label: NIGHTTIME SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride 50 mg capsule, liquid filled

  • NDC Code(s): 49035-237-16, 49035-237-96
  • Packager: EQUATE (Walmart Stores, Inc.)
  • 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 November 21, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
  • 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
    • trouble urinating due to an enlarged prostate gland

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

    When using this product avoid alcoholic drinks

    Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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.

  • Directions

    • adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor
  • Other information

    • store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

  • Questions or comments?

    Call toll free 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL - 32ct Carton and Bottle Label

    Nighttime Sleep-Aid Maximum Strength

    Diphenhydramine HCl, 50 mg 32 Softgels

    Compare to Unisom® SleepGels® Active Ingredient*

    NDC 49035-237-16

    Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

    *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

    32ct Carton Label

    32ct Bottle Label

  • PRINCIPAL DISPLAY PANEL - 96ct Bottle Label

    Nighttime Sleep-Aid Maximum Strength

    Diphenhydramine HCl, 50 mg 96 Softgels

    Compare to Unisom® SleepGels® Active Ingredient*

    NDC 49035-237-96

    Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

    *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

    96ct Bottle Label Front

    96ct Bottle Label Back

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID MAXIMUM STRENGTH 
    diphenhydramine hydrochloride 50 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-237
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULE (oblong) Size13mm
    FlavorImprint Code PC5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-237-161 in 1 CARTON10/31/2013
    132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49035-237-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/31/2013
    Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287MANUFACTURE(49035-237) , ANALYSIS(49035-237)
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