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Name:Meclizine Hydrochloride
Manufacturer:Cadista Pharmaceuticals Inc.
Category:Prescription Marketed Drugs


MECLIZINE HYDROCHLORIDE TABLETS, USPRx only

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.

Structure of Meclizine HCl

                          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.

Trademark of Cadista

Revised 04/09

PRINCIPAL DISPLAY PANEL

100 Counts of 12.5mg Tablets

NDC 59746-122-06
CADISTA

Meclizine Hydrochloride Tablets, USP
12.5 mg 
Rx only 
100 Tablets

100 Counts of 25mg 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 Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC:59746-122-06 100 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:59746-122-10 1000 TABLET ( 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 Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC:59746-121-06 100 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:59746-121-10 1000 TABLET ( 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: 06/2010 Cadista Pharmaceuticals Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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