Label: DIPHENHYDRAMINE HCL 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 February 1, 2023

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  • 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
  • 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 (800) 222-1222.

  • 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 age ask 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 room temperature, USP.
    • Do not use if either capsule band or imprinted safety seal under cap is broken
    • 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

  • 16 HOW SUPPLIED

    Diphenhydramine HCL capsules are available as follows:

    50 mg: pink with red band, capsule, debossed “CPC 836”. Available in bottles of

    10 capsules (NDC 43063-720-10)

    15 capsules (NDC 43063-720-15)

    20 capsules (NDC 43063-720-20)

    30 capsules (NDC 43063-720-30)

    40 capsules (NDC 43063-720-40)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-720(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:43063-720-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
    2NDC:43063-720-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2021
    3NDC:43063-720-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2021
    4NDC:43063-720-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2021
    5NDC:43063-720-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/02/2009
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-720)
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