MECLIZINE HYDROCHLORIDE

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

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

DESCRIPTION Chemically, Meclizine HCl is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. C 25 H 27 ClN 2 . 2HCl . H 2 O M . 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 #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%). Structure of Meclizine HCl

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.

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

WARNINGS Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a 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.

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 a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

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MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride Meclizine Hydrochloride Meclizine Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Fd&c Blue No. 1 Aluminum Oxide TL122 MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride Meclizine Hydrochloride Meclizine Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline D&c Yellow No. 10 Aluminum Oxide TL121

ANDA040659

MECLIZINE HYDROCHLORIDE

Meclizine Hydrocloride

35356-914

HUMAN PRESCRIPTION DRUG

ORAL

Image of 12.5mg Label image description

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) NDC: 35356-901-30 Bottles of 30 NDC: 35356-901-60 Bottles of 60 NDC: 35356-901-90 Bottles of 90 25 mg (Yellow, oval-shaped, scored, debossed with TL121) NDC: 35356-914-20 Bottles of 20 NDC: 35356-914-30 Bottles of 30 NDC: 35356-914-60 Bottles of 60 NDC: 35356-914-90 Bottles of 90 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 03/11

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.