DESCRIPTION

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

Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue # 1 Aluminum Lake.  The 25 mg tablet also contains D&C Yellow # 10 Aluminum Lake.

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

Management of nausea and vomiting, and dizziness associated with motion sickness.

CONTRAINDICATIONS

Meclizine HCl 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

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.

Pregnancy Use

Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine 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.

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 Hydrochloride Tablets 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 Hydrochloride Tablets, USP 12.5 mg are light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 42291-608-90
Bottles of 1000: NDC 42291-608-10

Meclizine Hydrochloride Tablets, USP 25 mg are light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 42291-609-90
Bottles of 1000: NDC 42291-609-10

Meclizine Hydrochloride Tablets, USP 50 mg are white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side.

They are available as follows:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 12/10
AV 04/12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291-608-10

Meclizine Hydrochloride Tablets, USP

12.5 mg
1000 Tablets        Rx Only

Each tablets contains:
Meclizine HCl..................12.5mg

Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature.]

Dispense in tight, light-resistant containers as defined in the USP.

DOSAGE AND USE: See accompanying prescribing information.

MOTION SICKNESS: 25mg to 50mg daily.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 02/11       AV 04/12

N3   42291 60810   8

AvKARE
NDC 42291-609-10

Meclizine Hydrochloride Tablets, USP

25 mg
1000 Tablets        Rx Only

Each tablets contains:
Meclizine HCl..................25mg

Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature.]

Dispense in tight, light-resistant containers as defined in the USP.

DOSAGE AND USE: See accompanying prescribing information.

MOTION SICKNESS: 25mg to 50mg daily.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 02/11       AV 04/12

N3   42291 60910   5