Label: TAVIST ALLERGY- clemastine fumarate tablet

  • NDC Code(s): 0067-1190-08, 0067-1190-16
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 09/11

If you are a consumer or patient please visit this version.

  • Active ingredient

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

    Close
  • Purpose

    Antihistamine

    Close
  • 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

    Close
  • Warnings
  • Ask Doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to enlargement of the prostate gland
    Close
  • Ask a doctor or pharmacist before use if you are

    taking sedative or tranquillizers

    Close
  • When using this product

    • avoid alcoholic drinks
    • drowsiness may occur
    • alcohol, sedative, and tranquillizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
    Close
  • If pregnant or breast-feeding,

    ask a health professional before use.

    Close
  • Keep Out of Reach of Children

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

    Close
  • 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 direction by a doctor
    • children under 12 years of age: consult a doctor
    Close
  • Other information

    • sodium free
    • store at controlled room temperature 20-25°C (68-77°F)
    Close
  • Inactive ingredients

    lactose, povidone, starch, stearic acid, talc

    Close
  • Questions or comments?

    call 1-800-452-0051

    Dist. by:

    Novartis Consumer Health, Inc.

    Parsippany, NJ 07054-0602

    Close
  • Principal Display
  • INGREDIENTS AND APPEARANCE
    TAVIST  ALLERGY
    clemastine fumarate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-1190
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID) CLEMASTINE FUMARATE 1.34 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color WHITE (WHITE) Score 2 pieces
    Shape CAPSULE (CAPSULE SHAPED TABLET) Size 10mm
    Flavor Imprint Code TAVIST
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-1190-08 1 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:0067-1190-16 2 in 1 CARTON
    2 16 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020925 01/01/2010
    Labeler - Novartis Consumer Health, Inc. (879821635)
    Establishment
    Name Address ID/FEI Business Operations
    Novartis Consumer Health 129836151 ANALYSIS, MANUFACTURE
    Close