DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION Motion Sickness The initial dose of 25 to 50 mg of Meclizine HCI should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

HOW SUPPLIED SECTION.

HOW SUPPLIED Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval-shaped, scored, debossed with TL122) Bottles of 100 NDC 59746-122-06 Bottles of 1000 NDC 59746-122-10 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 100 NDC 59746-121-06 Bottles of 1000 NDC 59746-121-10 Store at 20-25C (68-77F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 03/11.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE For the management of nausea and vomiting, and dizziness associated with motion sickness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel. Meclizine Hydrochloride Tablets, USP 25mg30 TabletsNDC 10544-081-30. 25mg 30ct.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY Meclizine Hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has marked effect in blocking the vasodepressor response to histamine, but only slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS Meclizine Hydrochloride is contraindicated in individuals who have shown previous hypersensitivity to it.

DESCRIPTION SECTION.

DESCRIPTION. Chemically, Meclizine HCl is 1-( p-chloro--phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. 25H 27ClN . 2HCl H 2O .W 481 .88 Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow 10 Aluminum Lake (15-20%). Structure.

PRECAUTIONS SECTION.

PRECAUTIONS PREGNANCY, Teratogenic Effects Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that medicine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary. Pediatric Use Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.

WARNINGS SECTION.

WARNINGS Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.