Label: ALLERGY RELIEF- diphenhydramine hcl tablet

  • 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 February 2, 2016

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  • Active ingredient (in each caplet)

    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
    • 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 a 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


    • 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 caplets
    • children 6 to under 12 years - 1 caplets
    • children under 6 years - do not use
  • Other Information


    • each caplet contains; calcium 20 mg
    • store between 20-25 C (68-77 F), Avoid high humidity. Protect from light.
  • Inactive Ingredients

    colloidal silicon dioxide, croscarmallose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, titanium dioxide, d and c red, lecithin, polyvinyl alcohol, polyethylene glycol, talc.

  • Questions or comments?

    Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • Principal Display Panel

    NDC: 70005-001-25

    We Care

    For Good Health

    ALLERGY RELIEF

    COMPARE TO THE ACTIVE INGREDIENT IN

    Benadryl

    CAPSULES

    TO OPEN PUSH IN TAB AND PULL OUT

    Diphenhydramine HCL, 25 mg

    Antihistamine

    Relieves:

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

    This product is not manufactured or distributed by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark of Benadryl Capsules.

    25 Pouches of 2 Coated Caplets

    image 25


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-001
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code EL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-001-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-001-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-001-022 in 1 BOX
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/11/2016
    Labeler - We Care Distributor Inc (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceutical Ltd.915664486manufacture(70005-001)
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