Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

  • NDC Code(s): 70692-784-02
  • 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 25mg

  • PURPOSE

    Sleep-aid

  • INACTIVE INGREDIENT

    polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.

  • DOSAGE & ADMINISTRATION

    • do not take more than directed (see overdose warning)
    • adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor
    • children under 12 years of age: do not use

  • INDICATIONS & USAGE

    • helps fall asleep faster
    • 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
    • with other drugs that cause drowsiness such as antihistamines and night-time cold/flu products

    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
    • 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

    • drowsiness may occur
    • avoid alcoholic drinks and other drugs that cause drowsiness

    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.
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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).
    • avoid excessive heat, cold and humidity.
    • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
  • PRINCIPAL DISPLAY PANEL

    784

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-784
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVAL (Oblong) Size14mm
    FlavorImprint Code 784
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-784-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product08/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01008/20/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)