Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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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

    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
     a breathing problem such as emphysema or chronic bronchitis

     glaucoma

     trouble urinating due to an enlarged prostate gland

    This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

    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 age

    do 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

    Inactive Ingredients: 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

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

    KEEP OUT OF REACH OF CHILDREN.

    DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.


    DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

    Distributed by:

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    Distributed by:

    Cardinal Health

    Dublin, OH 43017

    Product of China.

    Manufactured and packaged in the USA using domestic and imported ingredients.

    L58294370124

  • Principal Display Panel

    Diphenhydramine HCL Capsules

    25 mg

    10 Capsules

    Bag Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2344(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, UNSPECIFIED (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:55154-2344-010 in 1 BAG04/14/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/14/2022
    Labeler - Cardinal Health 107, LLC (118546603)
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