MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

Drug Labeling and Warnings

Drug Details [pdf]

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:

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.

Revised 03/11

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444

PRINCIPAL DISPLAY PANEL

NDC: 59746-121-010

CADISTA

Meclizine Hydrochloride Tablets, USP

25 mg

Rx only

1000 Tablets

Each tablet contains 25 mg of meclizine HCl.

DOSAGE AND USE 
See accompanying prescribing information

MOTION SICKNESS:
25 mg to 50 mg daily.

Dispense in tight, light-resistant containers (USP).

Store at 20-25°C (68-77°F)
[See USP Controlled Room temperature].

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA


Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444
Rev.# 03/11

Lot No.:

Exp Date:

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE  
meclizine hydrocloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52959-033(NDC:59746-121)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570)	Meclizine Hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Croscarmellose Sodium (UNII: M28OL1HH48)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
D&c Yellow No. 10 (UNII: 35SW5USQ3G)
Aluminum Oxide (UNII: LMI26O6933)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-033-04	4 in 1 BOTTLE
2	NDC: 52959-033-10	10 in 1 BOTTLE
3	NDC: 52959-033-15	15 in 1 BOTTLE
4	NDC: 52959-033-20	20 in 1 BOTTLE
5	NDC: 52959-033-21	21 in 1 BOTTLE
6	NDC: 52959-033-25	25 in 1 BOTTLE
7	NDC: 52959-033-30	30 in 1 BOTTLE
8	NDC: 52959-033-60	60 in 1 BOTTLE
9	NDC: 52959-033-90	90 in 1 BOTTLE
10	NDC: 52959-033-00	100 in 1 BOTTLE

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

Labeler - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Business Operations
JUBILANT CADISTA PHARMACEUTICALS, INC.		022490515	MANUFACTURE