Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

  • NDC Code(s): 70692-785-61
  • Packager: Strive Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • ACTIVE INGREDIENT

    Diphenhydramine HCl 50mg

  • PURPOSE

    Nighttime Sleep-aid

  • INACTIVE INGREDIENT

    FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

  • DOSAGE & ADMINISTRATION

    • do not take more than directed (see overdose warning)
    • adults and children 12 years of age and over: take 1 softgel at bedtime if needed, or as directed by doctor
    • children under 12 years of age: do not use

  • INDICATIONS & USAGE

    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

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as asthma, emphysema or chronic bronchitis

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

    When using this product

    • drowsiness will occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • sleeplessness persist 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

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20-25°C (68-77ºF).
  • PRINCIPAL DISPLAY PANEL

    LB78561CT78561

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-785
    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
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (greenish blue - transparent) Scoreno score
    ShapeOVAL (Oblong) Size13mm
    FlavorImprint Code 785
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-785-6116 in 1 BOTTLE; Type 0: Not a Combination Product08/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01008/20/2019
    Labeler - Strive Pharmaceuticals Inc. (080028013)
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