Label: DIPHENHYDRAMINE HCL capsule

  • NDC Code(s): 71399-1027-1, 71399-1027-2, 71399-1028-1, 71399-1028-2
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Active ingredient (in each banded capsule)

    Diphenhydramine Hydrochloride 25 mg and 50 mg

  • Purpose

    Antihistamine

  • Uses

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

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • 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
    • difficulty in urination due to enlargement of the 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 beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • 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.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

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

    25 mg Dosage:

    AgeDose
    adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in children under 6 years of age

    50 mg Dosage:

     Age Dose
     adults and children 12 years and over 1 capsules
     children under 12 years of age ask a doctor, the proper dosage
    strength is not available in this
    package**

    **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the
    25 mg. package.

  • Other information

    • store at temperature 15° to 30° C (59° to 86°F) 
    • do not use if either capsule band or imprinted safety seal under cap is broken or missing
    • protect from moisture
  • Inactive ingredients

    Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose, Sodium lauryl sulfate

  • Questions or comments?

    Call toll-free 1-877-225-6999

    Manufactured for:
    Akron Pharma, Inc,

    373 RT US 46 W, Building E,

    Suite 117, Fairfield, NJ 07004

  • PRINCIPAL DISPLAY PANEL

    25-100

    25-1000

    50-100

    50-1000

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-1027
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorpink (PINK WHITE) Scoreno score
    Shapecapsule (oblong) Size15mm
    FlavorImprint Code AD25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-1027-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2024
    2NDC:71399-1027-21000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/06/2024
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-1028
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorpink (PINK WHITE) Scoreno score
    Shapecapsule (oblong) Size15mm
    FlavorImprint Code AD50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-1028-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2024
    2NDC:71399-1028-21000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/06/2024
    Labeler - Akron Pharma Inc. (067878881)
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