Label: NIGHTTIME SLEEPAID- diphenhydramine hydrochloride capsule, gelatin coated

  • 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 October 22, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    nighttime sleep-aid

  • Uses

    • for the 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.
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid

    When using this product

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery

    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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

  • Directions

    • take only one dose per day (24 hours) - see Overdose warning
    adults & children
    12 yrs & over    		One dose = TWO 25 mg Softgels (50 mg)
    at bed time if needed or as directed by a doctor

  • Other information

    • store at 20-25° C (68-77° F)
    • avoid excessive heat above 40° C (104° F) and high humidity
    • Protect from light
  • Inactive ingredients

    FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water

  • SPL UNCLASSIFIED SECTION

    Exclusively distributed by:

    Kareway Product, Inc.

    2550 S. Dominguez Hills Dr.

    Compton, CA  90220

    Made in Korea

  • PRINCIPAL DISPLAY PANEL - 12 Capsule Carton

    image of carton label

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEPAID 
    diphenhydramine hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0557
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride50 mg  in 2 
    Inactive Ingredients
    Ingredient NameStrength
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    water (UNII: 059QF0KO0R)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code SLAD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0557-112 in 1 CARTON
    12 in 1 BLISTER PACK
    2NDC:67510-0557-224 in 1 CARTON
    22 in 1 BLISTER PACK
    3NDC:67510-0557-336 in 1 CARTON
    32 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33810/22/2014
    Labeler - Kareway Product, Inc. (121840057)
    Establishment
    NameAddressID/FEIBusiness Operations
    DongKoo Pharm. Ind. Co., Ltd.688235474manufacture(67510-0557)
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