WAL HIST 12 HOUR RELIEF (CLEMASTINE FUMARATE) TABLET [WALGREEN COMPANY]

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WAL HIST 12 HOUR RELIEF (CLEMASTINE FUMARATE) TABLET [WALGREEN COMPANY]
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NDC 0363-0707-73
Set ID a049607d-f5b1-4cdd-ada0-71003dd843ab
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA074512
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  • Active ingredient (in each tablet)

    Clemastine fumarate, USP 1.34 mg (equivalent to 1 mg clemastine)

  • Purpose

    Antihistamine

  • Uses

    temporarily reduces these symptoms of the common cold, hay fever, and other respiratory allergies:

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

    Ask a doctor before use if you have

    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    glaucoma
    •
    trouble urinating due to an enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    •
    avoid alcoholic drinks
    •
    drowsiness may occur
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    be careful 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.

  • Directions

    •
    adults and children 12 years of age and over: take 1 tablet every 12 hours; not more than 2 tablets in 24 hours unless directed by a doctor
    •
    children under 12 years of age: consult a doctor
  • Other information

    •
    sodium free
    •
    store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch, stearic acid

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    ORIGINAL PRESCRIPTION STRENGTH

    Wal-Hist

    12 Hour Relief

    Clemastine Fumarate Tablets USP 1.34 mg

    Antihistamine

    Relief of runny nose, sneezing, itchy throat & itchy, watery eyes

    12 HOUR

    Actual Size

    Compare to Tavist® Allergy active ingredient

    Wal-Hist Carton Image
  • INGREDIENTS AND APPEARANCE
    WAL HIST  12 HOUR RELIEF
    clemastine fumarate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID) CLEMASTINE FUMARATE1.34 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (off white) Score2 pieces
    ShapeCAPSULESize9mm
    FlavorImprint Code L282
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0707-732 in 1 CARTON
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07451205/31/1996
    Labeler - Walgreen Company (008965063)
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