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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 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 LABEL Item Code (Source) NDC:0067-1190
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLEMASTINE FUMARATE (CLEMASTINE) CLEMASTINE FUMARATE 1.34 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    POVIDONE  
    STARCH, CORN  
    STEARIC ACID  
    TALC  
    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