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Clemastine Fumarate Tablets

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Clemastine Fumarate Tablets

INDICATIONS

Clemastine fumarate tablets are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.

Clemastine fumarate tablets are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

It should be noted that clemastine is indicated for the dermatologic indications at the 2.68 mg dosage level only.

DOSAGE AND ADMINISTRATION

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.

The recommended starting dose is 1.34 mg (1/2 tablet) twice daily. Dosage may be increased as required. Clemastine fumarate tablets are recommended for the dermatologic indications at the 2.68 mg dosage level only.

The maximum recommended dosage is 2.68mg three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.

HOW SUPPLIED

Clemastine fumarate tablets, USP are available as:

2.68 mg: Round, white tablets, scored, debossed GG 160 on one side and plain on the reverse side and supplied as:

NDC 0781-1359-01 bottles of 100
NDC 0781-1359-05 bottles of 500
NDC 0781-1359-10 bottles of 1000

Store below 25° C. Dispense in a tight, light-resistant container.

Sandoz Inc. Princeton, NJ 08540. FDA Rev date: 12/16/02

Last reviewed on RxList: 8/11/2008
This monograph has been modified to include the generic and brand name in many instances.

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