Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 51316-835-01, 51316-835-03, 51316-835-07, 51316-835-08
  • Packager: CVS Pharmacy, Inc
  • 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 9, 2023

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  • Drug Facts

    Active ingredient (in each banded capsule)

    Diphenhydramine HCI 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

     temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat
     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

     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 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 (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 to 2 capsules
    children 6 to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in
    children under 6 years of age

  • Other information

     store in a dry place at 15° – 30°C (59° – 86°F)
     protect from moisture

  • INACTIVE INGREDIENT

    corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

  • QUESTIONS

    Questions or comments? 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

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

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2022 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS V-34601

    Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Benadryl®*

    Allergy Relief

    DIPHENHYDRAMINE HYDROCHLORIDE
    25 mg - Antihistamine

    Relief of: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

    100 CAPSULES

    CVS Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-835
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (half pink and half clear with white powder inside and sealed with red band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-835-011 in 1 CARTON12/01/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51316-835-07365 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2022
    3NDC:51316-835-034 in 1 CARTON12/01/2022
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:51316-835-082 in 1 CARTON11/16/2022
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/16/2022
    Labeler - CVS Pharmacy, Inc (062312574)
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