Label: DIPHENHYDRAMINE HCL capsule

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

Drug Label Information

Updated July 24, 2024

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

View All Sections
  • Active Ingredient (in each banded capsule)

    Diphenhydramine Hydrochloride 50 mg

  • Purpose

    Antihistamine

  • Use

    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
  • WARNINGS

    Do not use

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

    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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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.

  • Directions

    • Take every 4-6 hours
    • Do not take more than 6 doses in 24 hours
    adults and children 12 years of age and overTake 1 capsule (50 mg)
    children 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 in a dry place at 15° – 30°C (59° – 86°F).
    • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
    • 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?1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    Distributed by: MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    (800) 616-2471

    www.majorpharmaceuticals.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3650(NDC:0904-5307)
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-3650-44 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/02/2009
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals, Inc010632300repack(68071-3650)
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!