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Clemastin Indications, Dosage, Storage, Stability - Clemastine

Clemastin Indications, Dosage, Storage, Stability - Clemastine

INDICATIONS

Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and acrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION).

It should be noted that clemastine is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

DOSAGE AND ADMINISTRATION

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

Pediatric (Children aged 6 to 12 years)

For Symptoms at Allergic Rhinitis: The starting dose is 1 teaspoonful (0.5 mg clemastine) twice daily. Since single doses of up to 2.25 mg clemastine were well tolerated by this age group, dosage may be increased as required, but not to exceed 6 teaspoonfuls daily (3 mg clemastine).

For Urticaria and Angioedema: The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily, not to exceed 6 teaspoonfuls daily (3 mg clemastine).

Adults and Children 12 Years and Over

For Symptoms of Allergic Rhinitis: The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily. Dosage may be increased as required, but not to exceed 12 teaspoonfuls daily (6 mg clemastine).

For Urticaria and Angioedema: The starting dose is 4 teaspoonfuls (2 mg clemastine) twice daily, not to exceed 12 teaspoonfuls daily (6 mg clemastine).

HOW SUPPLIED

Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate 0.67 mg/5 mL). A clear, colorless liquid with a citrus flavor, in 120 mL bottle (NDC 0093-0309-12).

Store below 25° C (77° F).

CAUTION: Federal law prohibits dispensing without prescription.

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