CLEMASTINE FUMARATE

Each 5 mL (teaspoonful) of Clemastine Fumarate Syrup for oral administration contains clemastine 0.5 mg (present as clemastine fumarate 0.67 mg). Other ingredients: Alcohol 5.5%, Flavors, Maleic Acid, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sodium Hydroxide, and Sorbitol. Clemastine fumarate belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate and has the following structural formula: C 21 H 26 ClNO∙C 4 H 4 O 4 M.W. 459.97 Clemastine fumarate occurs as a colorless to faintly yellow, odorless, crystalline powder. Clemastine Fumarate Syrup has an approximate pH of 6.2. Chemical Structure

Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. 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 SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. Pediatric Children aged 6 to 12 years For Symptoms of 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).

Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS- Drug Interactions ). Antihistamines should not be used in newborn or premature infants . Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (see PRECAUTIONS-Nursing Mothers ).

The most frequent adverse reactions are italicized: Nervous System Sedation , sleepiness , dizziness , disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness. Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses. General Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Additive CNS depression may occur when antihistamines are administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. Patients receiving antihistamines should be advised against the concurrent use of other CNS depressant drugs. Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of antihistamines.

Store at controlled room temperature, between 20° and 25°C (68° and 77°F) (see USP).