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
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.
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