MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet
Aidarex Pharmaceuticals LLC

DESCRIPTION

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

Structure of Meclizine HCl
(click image for full-size original)

C25 H27 ClN2 . 2HCl. H2 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%).

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:
25 mg (Yellow, oval-shaped, scored, debossed with TL121)
Bottles of 8 NDC 33261–0718-08
Bottles of 10 NDC 33261–0718-10
Bottles of 20 NDC 33261–0718-20
Bottles of 30 NDC 33261–0718-30
Bottles of 60 NDC 33261–0718-60
Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature].

Manufactured By:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.

Repackaged By :
Aidarex Pharmaceuticals LLC,Corona, CA 92880

Revised 03/11

PRINCIPAL DISPLAY PANEL

IMAGE LABEL
(click image for full-size original)

NDC 33261-0718-30


Meclizine Hydrochloride Tablets, USP
25 mg
Rx only

30 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

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Rev.# 03/11
Lot No.:Exp Date:

MECLIZINE HYDROCHLORIDE meclizine hydrocloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-718(NDC:59746-121)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 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:33261-718-08 8 TABLET (8 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-718-10 10 TABLET (10 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:33261-718-20 20 TABLET (20 TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:33261-718-30 30 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:33261-718-60 60 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040659 06/04/2010
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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