Label: ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride 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 October 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients

    Diphenhydramine HCl 25 mg
  • PURPOSE

    Antihistamine

  • DOSAGE & ADMINISTRATION

    Directions • take every 4 to 6 hours • do
    not take more than 6 doses in 24 hours Adults
    and children 12 years of age and over: 1 to 2
    caplets • Children 6 to under 12 years of age: 1
    caplet • children under 6 years of age: do not use
    this product in children under 6 years of age

  • INDICATIONS & USAGE

    Uses: • temporarily relieves these symptoms due to hay fever
    or other upper respiratory allergies: • runny nose • sneezing
    • itchy, watery eyes • itchy nose or throat • temporarily relieves
    these symptoms due to the common cold: • runny nose
    • sneezing

  • WARNINGS

    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 machinery
    • excitability may occur, especially in children.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or
    breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    Inactive ingredients: carnauba wax,
    colloidal silicon dioxide, croscarmellose sodium, DC red 27
    aluminum lake, dibasic calcium phosphate dihydrate,
    hydroxypropylmethyl cellulose, hypromellose, lactose,
    magnesium stearate, microcrystalline cellulose, polyethylene
    glycol (PEG) 400, polysorbate 80, silicon dioxide, titanium
    dioxide

  • PRINCIPAL DISPLAY PANEL

    MM1

    antihistamine packet

  • INGREDIENTS AND APPEARANCE
    ALLERGY ANTIHISTAMINE  
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-460
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE (UNII: J2B2A4N98G)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Colorpink (rose pink) Scoreno score
    ShapeCAPSULE (T;061) Size11mm
    FlavorImprint Code T;061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-460-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)
    Registrant - Select Corporation (053805599)
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