Symptomatic relief of rhinorrhea, sneezing, lacrimation, itching eyes, or oronasopharyngeal itching associated with allergic rhinitis (e.g., hay fever) or other upper respiratory allergies.
Allergic Skin Disorders
Management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Common Cold
Self-medication for temporary relief of symptoms associated with the common cold (e.g., rhinorrhea, sneezing).
1.34 mg clemastine fumarate equivalent to 1 mg clemastine.
Individualize dosage according to patient’s response and tolerance.
Pediatric Patients
Allergic Conditions
Allergic Rhinitis
Oral
Children 6 to <12 years of age: Initially, 0.67 mg twice daily (as oral solution). Because single doses of up to 3.02 mg have been well tolerated, may increase dosage as necessary, not to exceed 4.02 mg daily.
Children ≥12 years of age: 1.34 mg every 12 hours (as tablets or oral solution); this is the maximum dosage recommended for self-medication. When used under the direction of a clinician, may increase dosage as necessary, not to exceed 8.04 mg daily.
Allergic Skin Disorders
Oral
Children 6 to <12 years of age: Initially, 1.34 mg twice daily (as oral solution). May increase dosage as necessary, not to exceed 4.02 mg daily.
Children ≥12 years of age: 2.68 mg 1–3 times daily (as tablets or oral solution), not to exceed 8.04 mg daily.
Common Cold
Oral
Self-medication in children ≥12 years of age: Usually, 1.34 mg every 12 hours (as tablets), not to exceed 2.68 mg daily unless otherwise directed by a clinician.
Adults
Allergic Conditions
Allergic Rhinitis
Oral
Initially, 1.34 mg every 12 hours (as tablets or oral solution); this is the maximum dosage recommended for self-medication. When used under the direction of a clinician, may increase dosage as necessary, not to exceed 8.04 mg daily.
Allergic Skin Disorders
Oral
2.68 mg 1–3 times daily (as tablets or oral solution), not to exceed 8.04 mg daily.
Common Cold
Oral
Self-medication: Usually, 1.34 mg every 12 hours (as tablets), not to exceed 2.68 mg daily unless otherwise directed by a clinician.
Prescribing Limits
Pediatric Patients
Allergic Conditions
Allergic Rhinitis
Oral
Children 6 to <12 years of age: Maximum 4.02 mg daily.
Children ≥12 years of age: For self-medication, maximum 1.34 mg every 12 hours. When used under the direction of a clinician, maximum 8.04 mg daily.
Allergic Skin Disorders
Oral
Children 6 to <12 years of age: Maximum 4.02 mg daily.
Children ≥12 years of age: Maximum 8.04 mg daily.
Common Cold
Oral
Children ≥12 years of age: For self-medication, maximum 2.68 mg daily unless otherwise directed by a clinician.
Adults
Allergic Conditions
Allergic Rhinitis
Oral
Self-medication: Maximum 1.34 mg every 12 hours. When used under the direction of a clinician, maximum 8.04 mg daily.
Allergic Skin Disorders
Oral
Maximum 8.04 mg daily.
Common Cold
Oral
Self-medication: Maximum 2.68 mg daily unless otherwise directed by a clinician.
Special Populations
Geriatric Patients
Reduce dosage if mild adverse effects occur. (See Geriatric Use under Cautions.)
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