Your browser does not support JavaScript! TAVIST ALLERGY (CLEMASTINE FUMARATE) TABLET [NOVARTIS CONSUMER HEALTH, INC.]
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TAVIST ALLERGY (clemastine fumarate) tablet
[Novartis Consumer Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Active ingredient

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 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

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 Allergy
TAVIST  ALLERGY
clemastine fumarate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-1190
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLEMASTINE FUMARATE (CLEMASTINE) CLEMASTINE FUMARATE1.34 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
TALC 
Product Characteristics
ColorWHITE (WHITE) Score2 pieces
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size10mm
FlavorImprint Code TAVIST
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-1190-081 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:0067-1190-162 in 1 CARTON
216 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02092501/01/2010
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIBusiness Operations
Novartis Consumer Health129836151ANALYSIS, MANUFACTURE

Revised: 9/2011
 
Novartis Consumer Health, Inc.

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