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TAVIST

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Antihistamine

TAVIST 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 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

Ask a doctor or pharmacist before use if you are

taking sedative or tranquillizers

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

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

TAVIST Other information

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

Inactive ingredients

lactose, povidone, starch, stearic acid, talc

Questions or comments?

call 1-800-452-0051

Dist. by:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0602

Principal Display

TAVIST

TAVIST

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 1.34 mg

Inactive Ingredients

Ingredient Name Strength
LACTOSE
povidone
STARCH, CORN
STEARIC ACID
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE (WHITE) 10 mm TAVIST CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 16 in 1 BLISTER PACK
3 NDC:0067-1190-16 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020925 2010-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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