MECLIZINE HYDROCHLORIDE   - meclizine hydrochloride tablet 
MECLIZINE HYDROCHLORIDE   - meclizine hydrochloride tablet 
Cadista Pharmaceuticals Inc.

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MECLIZINE HYDROCHLORIDE TABLETS, USP
Rx only

DESCRIPTION

Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

                          C25H27ClN2. 2HCl. H2O                                                                                        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%).

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.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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

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.

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.

ADVERSE REACTIONS

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

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

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 20-25°C (68-77°F) (See USP Controlled Room Temperature].

Manufactured By:

Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.

Revised 04/09

PRINCIPAL DISPLAY PANEL

NDC 59746-122-06
CADISTA
Meclizine Hydrochloride Tablets, USP
12.5 mg 
Rx only 
100 Tablets

NDC 59746-121-06
CADISTA
Meclizine Hydrochloride Tablets, USP
25 mg
Rx only
100 Tablets

MECLIZINE HYDROCHLORIDE   meclizine hydrochloride   tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59746-122 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meclizine Hydrochloride (Meclizine) Meclizine 12.5 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide   Croscarmellose Sodium   Lactose Monohydrate   Magnesium Stearate   Cellulose, Microcrystalline   Fd&c Blue No. 1   Aluminum Oxide

Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code TL122 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59746-122-06 100 TABLET In 1 BOTTLE None 2 59746-122-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040659	06/04/2010

MECLIZINE HYDROCHLORIDE   meclizine hydrocloride   tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59746-121 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meclizine Hydrochloride (Meclizine) Meclizine 25 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide   Croscarmellose Sodium   Lactose Monohydrate   Magnesium Stearate   Cellulose, Microcrystalline   D&c Yellow No. 10   Aluminum Oxide

Product Characteristics Color YELLOW Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code TL121 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59746-121-06 100 TABLET In 1 BOTTLE None 2 59746-121-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040659	06/04/2010

Labeler - Cadista Pharmaceuticals Inc. (022490515)

Revised: 06/2010Cadista Pharmaceuticals Inc.