CLEMASTINE FUMARATE tablet

Clemastine Fumarate by

Drug Labeling and Warnings

Clemastine Fumarate by is a Otc medication manufactured, distributed, or labeled by Carilion Materials Management. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)

Purpose

Antihistamine

Keep out of reach of children.

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

Uses

Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

Warnings

Ask a doctor before use if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant or breast-feeding,

aska health professional before use.

Directions

• adults and children 12 years and older:

  1 tablet every 12 hours; not more than 2 tablets in 24 hours

• children under 12 years:

  ask a doctor

Other Information

• Safety sealed: do not use if the imprinted bottle seal is open or torn.
• Store at 20°-25°C (68°-77°F).

Inactive Ingredients

Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).

Questions or comments?

1-800-525-8747

Clemastine Fumarate 1.34 MG TAB

INGREDIENTS AND APPEARANCE

CLEMASTINE FUMARATE 
clemastine fumarate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68151-2456(NDC: 0781-1358)
Route of Administration	ORAL

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 MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	CAPSULE (capsule shaped)	Size	4mm
Flavor		Imprint Code	GG;159
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68151-2456-0	1 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073458	10/31/1993

Labeler - Carilion Materials Management (079239644)

Registrant - Carilion Materials Management (079239644)

Establishment
Name	Address	ID/FEI	Business Operations
Carilion Materials Management		079239644	REPACK(68151-2456)