Label: CLEMASTINE FUMARATE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 9, 2012

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  • Active ingredient

    Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)

  • Purpose

    Antihistamine

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

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

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

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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

    • you may get drowsy
    • 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

    If pregnant or breast-feeding,

    aska health professional before use.

  • Directions

    adults and children 12 years and older:

    1 tablet every 12 hours; not more than 2 tablets in 24 hours

    children under 12 years:

    ask a doctor
  • Other Information

    • Safety sealed: do not use if the imprinted bottle seal is open or torn.
    • Store at 20°-25°C (68°-77°F).
  • Inactive Ingredients

    Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).

    Questions or comments?

    1-800-525-8747

  • Clemastine Fumarate 1.34 MG TAB

    Label Image
  • INGREDIENTS AND APPEARANCE
    CLEMASTINE FUMARATE 
    clemastine fumarate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-2456(NDC:0781-1358)
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeCAPSULE (capsule shaped) Size4mm
    FlavorImprint Code GG;159
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68151-2456-01 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07345810/31/1993
    Labeler - Carilion Materials Management (079239644)
    Registrant - Carilion Materials Management (079239644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carilion Materials Management079239644REPACK(68151-2456)
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