Home > Pill Identifier > Diphenhydramine Hydrochloride 50 MG Oral Capsule

Pill Identifier Information of Diphenhydramine Hydrochloride 50 MG Oral Capsule

Drug Information

Diphenhydramine Hydrochloride 50 MG Oral Capsule

Imprint: E649
Shape: C48336
Color: C48328
Ingredients: Diphenhydramine
Size: 14.00
Score: 1
Rxtty: SCD
Author: Physicians Total Care, Inc.
Inactive Ingredients: SILICON DIOXIDE / STARCH, CORN / D&C RED NO. 28 / FD&C BLUE NO. 1 / FD&C RED NO. 40 / GELATIN / ANHYDROUS LACTOSE / MAGNESIUM STEARATE / SILICON DIOXIDE / SODIUM LAURYL SULFATE>

Complete Information

  • Active ingredient (in each capsule)

    Diphenhydramine Hydrochloride 25 mg

    Diphenhydramine Hydrochloride 50 mg

  • Purpose

    Antihistamine

  • Uses

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

    • runny nose and sneezing
    • itching of the nose or throat
    • itchy, watery eyes.
  • Warnings

    Ask a doctor before use if you have

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

    Do not use with ny other product containing diphenhydramine, including products used topically.

    Ask a doctor or pharmacist before use if you are

    • taking tranquilizers or sedatives
    • taking other products containing diphenhydramine

    When using this product

    • Do not exceed recommended dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use caution when driving a motor vehicle or operating machinery

    If pregnant or breastfeeding ask a health professional before use.

  • Keep out of the reach of children.

     In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
    • Children 12 years and under: Consult a Doctor
  • Inactive ingredients

    Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

  • Storage and Handling

    Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

    Manufactured for Sandoz Inc.

    Princeton, NJ 08540

    Manufactured by Epic Pharma, LLC

    Laurelton, NY 11413

    L1812

    Rev. 11/08



    Relabeling and Repackaging by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma       74146

  • HOW SUPPLIED

    DiphenhydrAMINE Hydrochloride Capsules USP

    50 mg

    Bottles of 30
    		NDC 54868-1050-1
    Bottles of 100
    		NDC 54868-1050-5

  • Package Label - Principal Display Panel

    NDC 54868-1050-1

    50 mg x 30 Capsules - Label

    DiphenhydrAMINE

    Hydrochloride

    Capsules USP

    50 mg

    30 Capsules


  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1050(NDC:0185-0649)
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorPINK (pink top/pink body) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code E649
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-1050-130 in 1 BOTTLE
    2NDC:54868-1050-5100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2000
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel, repack
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