Label: ALLERGY RELIEF- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 59779-923-03, 59779-923-06, 59779-923-07, 59779-923-08, view more
    59779-923-12, 59779-923-22, 59779-923-51
  • Packager: CVS Pharmacy
  • 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 May 7, 2020

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • sneezing
      • 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
    • difficulty in urination due to enlargement of the 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 beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution 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 to 6 hours, or as directed by a doctor

    • do not take more than 6 times in 24 hours

    adults and children 12
    years and over

    1 to 2 tablets

     children 6 to under
    12 years
     1 tablet  

     children under 6 years  
     do not use 
  • Other information

    • each tablet contains: calcium 30 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • use by expiration date on package
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

  • Principal Display Panel

    ♥︎CVSHealth™

    Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*

    Allergy Relief

    DIPHENHYDRAMINE
    HYDROCHLORIDE, 25 mg
    Antihistamine

    Relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes,
    • Itchy throat

    10 TABLETS     Actual Size

    TAMPER EVIDENT: USE ONLY IF THIS BLISTER IS INTACT

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

    50844     ORG101632903

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2020 CVS/pharmacy
    CVS.com®  1-800-SHOP  CVS  V-18615

    CVS 44-329

    CVS 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-923
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-923-071 in 1 CARTON03/02/199007/08/2018
    136 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59779-923-082 in 1 CARTON03/02/1990
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:59779-923-224 in 1 CARTON03/02/1990
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:59779-923-031 in 1 PACKAGE03/02/1990
    410 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59779-923-061 in 1 CARTON03/02/1990
    5200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:59779-923-121 in 1 CARTON03/02/1990
    6100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:59779-923-51365 in 1 BOTTLE; Type 0: Not a Combination Product03/02/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/02/1990
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(59779-923)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(59779-923)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(59779-923) , PACK(59779-923)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(59779-923)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(59779-923)