Label: BENADRYL ALLERGY- diphenhydramine hydrochloride solution

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

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl 12.5 mg

  • 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 the user has

    • a breathing problem such as chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if the user is 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 right away. (1-800-222-1222)

  • Directions

    • find right dose on chart below
    • mL = milliliter
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    Age (yr)Dose (mL)
    adults and children
    12 years and over     		10 mL to 20 mL (2x10 mL;
    Note: dosing cup needs to
    be filled to 10 mL line twice
    for the 20 mL dose)
    children 6 to 11 years5 mL to 10 mL
    children 2 to 5 yearsdo not use unless directed
    by a doctor
    children under 2 yearsdo not use

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    ■ each 5 mL contains: sodium 14 mg
    ■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used.
    ■ do not use if carton is opened
    ■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

  • Inactive ingredients

    anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

    call 1-877-717-2824 or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-573-04

    NEW DOSING FOR ADULTS

    Benadryl ®

    ALLERGY

    LIQUID

    Diphenhydramine HCl/antihistamine
    12.5 mg/5 mL oral solution

    Same as Children’s Benadryl® Allergy Liquid

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    Alcohol Free

    Wild Cherry

    Flavored Liquid

    4 fl oz (118 mL)

    benadryl-1

  • INGREDIENTS AND APPEARANCE
    BENADRYL ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-573
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-573-041 in 1 CARTON12/02/2024
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/02/2024
    Labeler - Kenvue Brands LLC (118772437)
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