Label: ALLERGY RELIEF DIPHENHYDRAMINE HCL, 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable

  • NDC Code(s): 51316-701-03, 51316-701-08
  • Packager: CVS Pharmacy, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2023

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  • Active ingredient (in each piece)

    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 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 (for 20 pieces pack)

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours

    Age (yr)

    Dose (Piece)

     Adults and children 12 years and over

     1 to 2 Pieces (25 mg to 50 mg)

     Children 6 to 11 years

     1 Piece (25 mg)

     Children under 6 years

     Do not use
  • Directions (For 10 pieces pack: For Adult Use Only)

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    • chew each piece thoroughly before swallowing

    Age (yr)

    Dose(Piece)

    Adults and children 12 years and over

    1 to 2 Pieces (25 mg to 50 mg)

    Children under 12 years

    Do not use
  • Other information

    • each piece: contains sodium 9 mg.

    low sodium

    • store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container; do not use if printed seal under cap is broken or missing.
  • Inactive ingredients:

    FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

  • SPL UNCLASSIFIED SECTION

    Questions or comments?
    Call 1-800-227-6151

  • Principal display Panel-25 mg label-20 pieces

    CVS Health Compare to the active ingredient in Benadryl ®Allergy*

    Soft Chews

    NDC 51316-701-08
    Allergy Relief DIPHENHYDRAMINE HCl, 25 mg Antihistamine

    Gummy Bite

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

    Mixed Berry Flavor

    20 PIECES

    Principal display Panel-25 mg label-20 pieces

  • Principal display Panel-25 mg label-10 pieces: For Adult Use Only

    CVS Health

    Compare to the active ingredient in Benadryl® Allergy*

    Soft Chews

    NDC 51316-701-03

    Allergy Relief

    DIPHENHYDRAMINE HCI, 25 mg

    Antihistamine

    Relief of:

    • Sneezing • Itchy, watery eyes

    • Runny nose • Itchy throat

    Mixed Berry Flavor

    10 PIECES

    For Adult Use Only

    Principal display Panel-25 mg label - 10 count
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF DIPHENHYDRAMINE HCL, 25 MG ANTIHISTAMINE 
    diphenhydramine hcl bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-701
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    ACACIA (UNII: 5C5403N26O)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    MALTITOL (UNII: D65DG142WK)  
    NEOTAME (UNII: VJ597D52EX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Colorpink (Light pink to red pink) Scoreno score
    ShapeRECTANGLESize23mm
    FlavorBERRY (Mixed Berry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-701-0820 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2023
    2NDC:51316-701-0310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/21/2023
    Labeler - CVS Pharmacy, Inc. (062312574)
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