Label: HISTAPRIN- diphenhydramine 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 July 11, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient (in each caplet)

    Diphenhydramine Hydrochloride 25mg

  • PURPOSE

    Antihistamine
  • INDICATIONS & USAGE

    Temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • WARNINGS

    Do not use with any other products containing diphenhydramine, even one used on skin
  • ASK DOCTOR

    Ask a doctor before use if you have
    • trouble urinating due to enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchiti
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

  • WHEN USING

    When using the product
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • use caution 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. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Do not take more than directed

    Adults and children 12 years of age and over:

    • Take 1 caplet every 4 to 6 hours while symptoms persist
    • do not take more than 6 caplets in 24 hours unless directed by a doctor
    Children under 12 years of age: not intended for use in children under 12; ask a doctor
  • INACTIVE INGREDIENT

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    5645 Histaprin 11s.jpg

  • INGREDIENTS AND APPEARANCE
    HISTAPRIN 
    diphenhydramine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0132
    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)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code T061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0132-450 in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/01/2009
    Labeler - NorMed (069560969)
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