DESCRIPTION

Chemically, meclizine hydrochloride, USP is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. The molecular weight is 481.88 g/mole. It has the following structural formula:

Meclizine hydrochloride tablets, USP are available in three different strengths, 12.5 mg, 25 mg and 50 mg.

Inert ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.

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 tablets are 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

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg, 25 mg or 50 mg of meclizine hydrochloride, USP.

The 12.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 12 on the other side. They are available as follows:

NDC 0378-5485-77
bottles of 90 tablets

NDC 0378-5485-01
bottles of 100 tablets

NDC 0378-5485-10
bottles of 1000 tablets

The 25 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 25 on the other side. They are available as follows:

NDC 0378-5486-77
bottles of 90 tablets

NDC 0378-5486-01
bottles of 100 tablets

NDC 0378-5486-10
bottles of 1000 tablets

The 50 mg tablets are white to off-white, round, scored tablets debossed with M on one side of the tablet and MCZ above the score and 50 below the score on the other side. They are available as follows:

NDC 0378-5487-77
bottles of 90 tablets

NDC 0378-5487-05
bottles of 500 tablets

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

MARCH 2011
MECL:R1

PRINCIPAL DISPLAY PANEL - 12.5 mg

NDC 0378-5485-77

Meclizine
Hydrochloride
Tablets, USP
12.5 mg

Rx only 90 TABLETS

Each tablet contains:
Meclizine
hydrochloride, USP 12.5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

MOTION SICKNESS: 25 mg to 50 mg
daily.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

www.mylan.com

RM5485MM

PRINCIPAL DISPLAY PANEL - 25 mg

NDC 0378-5486-77

Meclizine
Hydrochloride
Tablets, USP
25 mg

Rx only 90 TABLETS

Each tablet contains:
Meclizine
hydrochloride, USP 25 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

MOTION SICKNESS: 25 mg to 50 mg
daily.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

www.mylan.com

RM5486MM

PRINCIPAL DISPLAY PANEL - 50 mg

NDC 0378-5487-77

Meclizine
Hydrochloride
Tablets, USP
50 mg

Rx only 90 TABLETS

Each tablet contains:
Meclizine
hydrochloride, USP 50 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

MOTION SICKNESS: 25 mg to 50 mg
daily.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

www.mylan.com

RM5487MM