Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 0904-7237-24, 0904-7237-60, 0904-7237-61, 0904-7237-80
  • Packager: Major Pharmaceuticals
  • 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 14, 2022

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  • Drug Facts

    Active ingredient (in each capsule)
    Diphenhydramine HCl 25 mg

  • PURPOSE

    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

     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 a Poison Control Center right away (1-800-222-1222).

  • Directions

     take every 4 to 6 hours, or as directed by a doctor

     do not take more than 6 doses in 24 hours

    adults and children
    12 years of age and over     		1 to 2 capsules
    children 6 to
    under 12 years of age     		1 capsule
    children under 6 years of agedo not use this product
    in children under 6 years of age

  • Other information

     store in a dry place at 15° – 30°C (59° – 86°F)

  • INACTIVE INGREDIENT

    corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

  • Questions or comments?

    1-800-616-2471

  • SPL UNCLASSIFIED SECTION

    Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

    Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

    To preserve quality and freshness, keep bottle tightly closed.

    KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
    TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
    DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL

    Major

    BENOPHEN

    NDC 0904-7237-80

    Complete Allergy Medication

    Diphenhydramin HCl 25 mg

    Antihistamine

    For the temporary relief of the symptoms of:
    • Upper Respiratory Allergies

    • Hay Fever

    Compare to the active ingredient in BENADRYL®*

    1000 CAPSULES

    EACH CAPSULE INDIVIDUALLY
    BANDED FOR YOUR PROTECTION

    Major Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7237
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (Half pink and half clear with white powder inside and sealed with red band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7237-801000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2022
    2NDC:0904-7237-60100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2022
    3NDC:0904-7237-242 in 1 CARTON04/14/2022
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0904-7237-6110 in 1 BOX, UNIT-DOSE04/14/2022
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/14/2022
    Labeler - Major Pharmaceuticals (191427277)
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