Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • 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 June 5, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!