SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [MEIJER, INC.]

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SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [MEIJER, INC.]
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NDC 41250-659-32
Set ID 40419127-2798-4d90-be5d-3e686bd357fd
Category HUMAN OTC DRUG LABEL
Packager MEIJER, INC.
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    For 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 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 (1-800-222-1222).

  • Directions

    • adults and children 12 years of age and older: 1 softgel  (50 mg) at bedtime if needed, or as directed by a doctor


  • Other information

    • store between 15-30ºC (59-86ºF)
  • Inactive ingredients

    edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan*, sorbitol

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the active ingredient in Unisom® SleepGels®*

    MAXIMUM STRENGTH

    Sleep Aid

    Diphenhydramine HCl | 50 mg

    Nighttime Sleep-Aid

    Safe, non-habit forming

    SOFTGELS

    ONE SOFTGELS PER DOSE

    †This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • Product Label

    Diphenhydramine HCL 50 mg

    MEIJER Maximum Strength Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID  NIGHTTIME
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-659
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code P50;A99;D50;AP018
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-659-321 in 1 BOX04/30/201912/27/2024
    132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:41250-659-641 in 1 BOX04/30/201912/27/2024
    264 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33804/30/201912/27/2024
    Labeler - MEIJER, INC. (006959555)
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