Meclizine Hydrochloride

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

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

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

Meclizine hydrochloride is an antihistamine that 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.

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.

Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

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.

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For the treatment of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

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

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 43063-662-10
bottles of 10 tablets

NDC 43063-662-15
bottles of 15 tablets

NDC 43063-662-30
bottles of 30 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.

PRINCIPAL DISPLAY PANEL - 25 mg

Meclizine

Hydrochloride

Tablets, USP

25 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL