Label: DIPHENHYDRAMINE HCL tablet, coated

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

Drug Label Information

Updated February 1, 2024

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  • Drug Facts

    Active ingredient (in each caplet)

    Diphenhydramine HCl 50 mg

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

    temporarily relives symptoms due to hay fever or other upper respiratory allergies:

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

    temporarily relives 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • 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 mau 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 brest-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 (1-800-222-1222) right away.

  • Directions

    take every 4 to 6 hours, or as directed by a doctor

    do not take more than 6 doses in 24 hours

    adults and children 12 years of age and over1 caplet
    children under 12 years of agedo not use

  • Other information

    • store in a dry place at 15º - 30º C (59º - 86º F).
    • ptotect from moisture

  • INACTIVE INGREDIENT

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin.

  • QUESTIONS

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2024 CVS/pharmacy CVS.com® 1-800-SHOP CVS
    Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
    V-34601

    TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN.

    RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION.

    * This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Benadryl® Allergy Extra Strength*

    Extra Strength

    Allergy Relief

    Diphenhydramine HCl, 50mg

    Antihistamine

    Temporatry relief of

    Sneezing

    Itchy throat

    Runny nose

    Itchy, watery eyes

    24 Caplets

    CVS Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-221
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code C110
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-221-082 in 1 CARTON01/31/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/31/2024
    Labeler - CVS Pharmacy, Inc. (062312574)
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