Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

  • 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 April 12, 2022

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  • ACTIVE INGREDIENT

    Diphenhydramine HCl 25mg

  • PURPOSE

    Antihistamine

  • INACTIVE INGREDIENT

    polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30

  • DOSAGE & ADMINISTRATION

    If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours

    AgeDaily dosage
    Adults and children 12 years of age or older1 to 2 softgel
    Children 6 to under 12 years1 softgel
    Children under 6 years of agedo not use this product

  • INDICATIONS & USAGE

    temporarily relieves these symptoms due to hay fever or other respiratory allergies:

    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes

    temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing
  • WARNINGS

    Do not use

    • to make a child sleepy
    • 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 emphysema or chronic bronchitis

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

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, expecially in children

    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 between 20-25°C (68-77ºF), Excursions permitted between 15°C-30°C (59-86ºF).
    • 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

    CT78302

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-783
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite (Natural Transparent) Scoreno score
    ShapeOVAL (Oblong) Size14mm
    FlavorImprint Code 783
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-783-0220 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 finalpart34108/20/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)
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