Label: SLEEP AID- diphenhydramine hcl capsule

  • NDC Code(s): 55910-894-16
  • Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    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 (1-800-222-1222) right away.

  • Directions

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

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

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

  • Principal Display Panel

    MAXIMUM STRENGTH

    Nighttime

    Sleep Aid

    Diphenhydramine HCL 50 mg

    Softgels

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

  • Package Label

    Diphenhydramine HCl 50 mg

    REXALL Maximum Strength Nighttime Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-894
    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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code P50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-894-1616 in 1 CARTON03/18/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/18/2021
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
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