CLEMASTINE FUMARATE- clemastine fumarate tablet 
Sandoz Inc

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Drug Facts

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,

ask a 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

1.34 mg Label

Clemastine Fumarate 1.34 mg Label

NDC 0781-1358-01

Clemastine

Fumarate

Tablets, USP

1.34 mg

Antihistamine

12 Hour Relief

Relief of: Sneezing Runny Nose

Itchy, Watery Eyes

100 Tablets

SANDOZ

CLEMASTINE FUMARATE 
clemastine fumarate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0781-1358
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 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
ColorWHITEScore2 pieces
ShapeCAPSULE (capsule shaped) Size4mm
FlavorImprint Code GG;159
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-1358-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/31/199310/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07345810/31/199310/31/2016
Labeler - Sandoz Inc (110342024)

Revised: 2/2016
 
Sandoz Inc