Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

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

Drug Label Information

Updated December 12, 2023

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  • Active Ingredient (in each banded capsule)

    Diphenhydramine HCl… 25 mg

    Diphenhydramine HCl… 50 mg

  • Purpose

    Antihistamine

  • Use

    25 MG

    • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itchy throat and nose
    • Temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing

    50 MG

    • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
      • sneezing
      • runny nose
      • itchy, watery eyes
      • itchy throat and nose
  • WARNINGS

    Do not use

    25 MG

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    50 MG

    • to make a child sleepy
    • with any other product containing diphenhydramine, including one applied topically
  • Ask a doctor before use if you have

    25 MG

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    50 MG

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the 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.

  • Directions

    • Take every 4-6 hours
    • Do not take more than 6 doses in 24 hours

    25 MG

    adults and children 12 years of age and over1 to 2 capsules
    children 6 years 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

    adults and children 12 years of age and over1 capsule
    children 6 years to under 12 years of ageAsk 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 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
    • Protect from moisture
    • Contains lactose
  • Inactive Ingredients

    D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

  • Questions?

    Questions or comments? (800) 616-2471

  • Distributed by

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233,

    Livonia, MI 48152

  • HOW SUPPLIED

    Product: 50090-3867

    NDC: 50090-3867-1 28 CAPSULE in a BOTTLE

    NDC: 50090-3867-0 30 CAPSULE in a BOTTLE

  • Diphenhydramine Hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3867(NDC:0904-5306)
    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)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (half pink and half clear with white powder inside) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3867-128 in 1 BOTTLE; Type 0: Not a Combination Product11/27/2018
    2NDC:50090-3867-030 in 1 BOTTLE; Type 0: Not a Combination Product11/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/02/2009
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3867) , REPACK(50090-3867)
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