Label: SLEEP AID- diphenhydramine hcl capsule

  • NDC Code(s): 55319-735-32
  • Packager: Family Dollar (FAMILY WELLNESS)
  • 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 15, 2018

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

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

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  • Purpose

    Nighttime sleep-aid

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  • Use

    for relief of occasional sleeplessness.

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  • Warnings

    Do not use

    • in children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if

    • 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).

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  • Directions

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

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

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

    *contains one or more of these ingredients

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  • Questions or comments?

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

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  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPGELS®†

    NIGHTTIME

    Sleep-Aid

    Diphenhydramine HCl, 50 mg

    Help to Reduce Difficulty Falling Asleep

    SOFTGELS

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    10611 MONROE RD., MATTHEWS NC 2810

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  • Product Label

    Diphenhydramine HCI 50 mg

    FAMILY WELLNESS Sleep-Aid

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  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-735
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 13mm
    Flavor Imprint Code P50;A99;D50;AP018
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-735-32 1 in 1 BOX 09/30/2018
    1 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 09/30/2018
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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