Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet, coated

  • 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 May 17, 2013

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  • Drug Facts

  • Active ingredient (in each Caplet)

    Diphenhydramine HCl 25 mg

  • Purposes

    Antihistamine

  • Uses

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • itching of the nose and throat
    • sneezing
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin.
    • to make a child sleepy.

    Ask a doctor before use if you have

    • glaucoma
    • difficulty in urinating due to an enlargement of the 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 effect
    • use caution 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

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

    Adults and children 12 years and older

    • 1 or 2 caplets (25mg to 50mg)

    Children under 12years

    • ask a doctor
  • Other Information

    • Store at room temperature
    • keep lid tightly closed in dry place
    • Do not use if imprinted safety seal under cap is broken or missing
  • Inactive Ingredients

    Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate Dihydrate, Hydroxypropyle MethylCellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silica, Stearic Acid and Titanium Dioxide.

  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

  • PRINCIPAL DISPLAY PANEL

    Diphenhydramine 25mg, 100ct caplets

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53598-004
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite ((Coated with pink film)) Scoreno score
    ShapeOVAL ((biconvex)) Size11mm
    FlavorImprint Code G17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53598-004-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/21/2013
    Labeler - Bonita Pharmaceuticals LLC (004219442)
    Registrant - Bonita Pharmaceuticals LLC (004219442)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bonita Pharmaceuticals LLC004219442label(53598-004)
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