Label: DIPHENHYDRAMINE HCL capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 8, 2019

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

  • Active ingredient (in each banded capsule)

    Diphenhydramine Hydrochloride 50 mg

  • Purpose

    Antihistamine

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Uses

    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.

    When using this product - marked drowsiness may occur - avoid alcoholic drinks - alcohol, sedatives, and tranquilizers may increase drowsiness – use caution when driving a motor vehicle or operating machinery- excitability may occur, especially in children.

  • Warnings

    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.

    This package is intended for institutional use only. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions-Take every 4 to 6 hours- do not take more than 6 doses in 24 hours

    adults and children 12 years of age and over

    1 capsule

    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.

    STORAGE: Store at 20 - 25C (68-77F); excursions permitted to 15 – 30C (59-86F) [See USP Controlled Room Temperature]

    Protect from moisture

    - contains lactose

    DO NOT USE IF BLISTER UNIT IS BROKEN

    Warnings

    Do not use - to make a child sleepy - with any other product containing diphenhydramine, including one applied topically

    Ask a doctor before use if you have - glaucoma -a breathing problem such as emphysema or chronic bronchitis – difficulty in urination due to an enlargement of the prostate gland

  • Inactive ingredients

    D&C Red No.28, FD&C Blue No.1, FD&C Red No.40, Gelatin, Lactose and Starch

    Questions or comments? (800) 616-2471

    Distributed by

    MAJOR® PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150 USA

    MFGD By CPC, NY 11788

    Re-Order No. 301575

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L32991870218

  • Package/Label Principal Display Panel

    Diphenhydramine HCl

    Capsules 50 mg.

    10 Capsules

    bag label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0661(NDC:0904-2056)
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (red center band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-0661-010 in 1 BAG01/02/2009
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/02/2009
    Labeler - Cardinal Health (603638201)