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Benadryl (Rebel Distributors Corp)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 3 BLISTER PACK in 1 CARTON (21695-811-24) > 8 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Benadryl Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each gelcap)

    Diphenhydramine HCl 25 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 you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    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 right away. (1-800-222-1222)


  • Directions

    • if needed, repeat dose every 4 to 6 hours
    • do not take more than 6 times in 24 hours
    adults and children 12 years of age and over 1 to 2 gelcaps
    children 6 to under 12 years of age 1 gelcap
    children under 6 years of age do not use this product in children under 6 years of age

  • Other information

    • each gelcap contains: calcium 35 mg
    • store between 20-25°C (68-77°F). Avoid high humidity.
    • do not use if carton is open or if blister unit is broken
    • see side panel for lot number and expiration date

  • Inactive ingredients

    benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, crospovidone, D&C red #28, dibasic calcium phosphate dihydrate, edetate calcium disodium, FD&C red #40, gelatin, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, titanium dioxide, yellow iron oxide


  • Questions or comments?

    call 1-877-717-2824


  • PRINCIPAL DISPLAY PANEL

    Benadryl 25mg


  • INGREDIENTS AND APPEARANCE
    BENADRYL  ALLERGY
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-811(NDC:50580-580)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    butylparaben (UNII: 3QPI1U3FV8)  
    Product Characteristics
    Color PINK, WHITE (with gray subcoat band) Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code Ben;A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-811-24 3 in 1 CARTON
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK