Label: HISTAPRIN- diphenhydramine tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 25, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient (in each caplet)

    Diphenhydramine Hydrochloride 25mg

  • PURPOSE

    Purpose:

    Antihistamine

  • INDICATIONS & USAGE

    Uses:

    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

    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 bronchitis
  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this 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. 1-800-222-1222

  • 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: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information:

    • each caplet contains calcium 30mg
    • caplet enclosed in a sealed packet
    • do not use if packet is torn, cut, or open
    • store at 59° to 86°F (15°-30°C) in a dry place
    • avoid excessive heat and humidity
    • protect from light and moisture
  • INACTIVE INGREDIENT

    corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    5645Histaprinv23f.jpg

  • INGREDIENTS AND APPEARANCE
    HISTAPRIN 
    diphenhydramine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0150
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0150-450 in 1 BOX, UNIT-DOSE01/01/2023
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01/01/2023
    Labeler - NorMed (069560969)