Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

  • NDC Code(s): 35916-0435-1
  • Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2024

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  • Actice ingredient

    (in each softgel)

    Diphenhydramine Hydrochloride USP 25mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:

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

    temporarily relieves these symptoms due to the common cold:

    runny nose
    sneezing

  • 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

    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

    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, especially in children

  • 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 aPoison Control Center right away. (1-800-222-1222)

  • Directions

    take every 4 to 6 hours
    do not take more than 6 doses in 24 hours

    adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years1 capsule
    children under 6 yearsdo not use this product in children under 6 years of age

  • Other Information

    store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.


    do not use if carton is open or blister unit is broken

  • Inactive Ingredients

    Propylene Glycol, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified water.

  • PRINCIPAL DISPLAY PANEL

    NDC 35916-0435-1

    Diphenhydramine Hydrochloride USP 25 mg | Antihistamine

    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat

    DYE-FREE

    *liquid-filled capsules

    Actual Size

    BAR CODE

    30 CAPSULES

    Diphenhydramine Hydrochloride Capsules USP 25 mg Carton

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0435
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite ((Clear)) Scorescore with uneven pieces
    ShapeCAPSULE ((Oblong)) Size15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0435-13 in 1 CARTON; Type 0: Not a Combination Product08/07/2023
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/07/2023
    Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0435)
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