TAVIST ALLERGY- clemastine fumarate tablet 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

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 DRUGItem Code (Source)NDC:0067-1190
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, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
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 CARTON01/01/201001/31/2013
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0067-1190-162 in 1 CARTON01/01/201001/31/2013
216 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02092501/01/201001/31/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2013
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC