Clemastine

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Clemastine can be taken with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

Usual Adult Dose for Allergic Rhinitis:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Adult Dose for Urticaria:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Adult Dose for Allergic Reaction:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day

Usual Pediatric Dose for Allergic Reaction:

< 6 years:

0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.

6 to 12 years:

0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.

> 12 years:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Pediatric Dose for Allergic Rhinitis:

< 6 years:

0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.

6 to 12 years:

0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.

> 12 years:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Pediatric Dose for Urticaria:

< 6 years:

0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.

6 to 12 years:

0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.

> 12 years:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

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 2.68 mg 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.

Rev. 08-2006M

7097

Sandoz Inc.

Princeton, NJ 08540

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Syrup, Oral, as fumarate:

Generic: 0.67 mg/5 mL (120 mL [DSC])

Tablet, Oral, as fumarate:

Dayhist Allergy 12 Hour Relief: 1.34 mg [scored; sodium free]

Tavist Allergy: 1.34 mg [scored; sodium free]

Generic: 1.34 mg [DSC], 2.68 mg

• Ethanolamine Derivative
• Histamine H1 Antagonist
• Histamine H1 Antagonist, First Generation

Refer to adult dosing.

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

• Asthma: Use with caution in patients with a history of asthma. Antihistamines should not be used to treat lower respiratory symptoms (including asthma).

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).

• Increased intraocular pressure: Use with caution in patients with increased intraocular pressure or angle-closure (narrow angle) glaucoma.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia, bladder neck obstruction, and/or GU obstruction.

• Pyloroduodenal obstruction: Use with caution in patients with pyloroduodenal obstruction (including stenotic peptic ulcer).

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Monitor therapeutic response (eg, reduction of rhinitis, urticaria, eczema, pruritus, or other allergic symptoms)

Consult your pharmacist.