Clemastine Fumarate description, usages, side effects, indications, overdosage, supplying and lots more!

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Clemastine Fumarate

Sandoz Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Clemastine Fumarate 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

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 Type Human otc drug label Item Code (Source) NDC:0781-1358
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CLEMASTINE FUMARATE CLEMASTINE 1.34 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
STARCH, CORN
cellulose, microcrystalline
HYPROMELLOSE 2910 (3 MPA.S)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 4 mm GG;159 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0781-1358-01 100 in 1 BOTTLE

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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