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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID)	CLEMASTINE FUMARATE	1.34 mg

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Carilion Materials Management (079239644)

Registrant - Carilion Materials Management (079239644)

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

Drug Facts