Label: CHILDRENS BENADRYL CHEWABLES- diphenhydramine hydrochloride tablet, chewable

  • NDC Code(s): 50580-232-01
  • Packager: Johnson & Johnson Consumer 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 March 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    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
  • 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 alcohol 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 healthcare 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
    • 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 (chewable tablets)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
    adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)
  • Other information

    • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
    • do not use if carton or blister unit is opened or broken/unsealed
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-232-01

    Children's
    Benadryl ®

    ALLERGY

    Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets

    Chewables

    4-6 Hours/Dose

    RELIEF OF:

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

    20
    Chewable Tablets

    Grape!
    Flavored
    Tablets

    Actual Size

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CHILDRENS BENADRYL CHEWABLES 
    diphenhydramine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ACACIA (UNII: 5C5403N26O)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TARTARIC ACID (UNII: W4888I119H)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-232-012 in 1 CARTON07/11/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/11/2016
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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