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 30: NDC 65162-441-03

 

Bottles of 100: NDC 65162-441-10

 

 

Bottles of 500: NDC 65162-441-50

 

 

Bottles of 1000: NDC 65162-441-11

 

 

Blister packs: NDC 65162-441-60

 

 

(Packages of 100 unit doses, 10 cards of 10 tablets each)

 

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 30: NDC 65162-442-03

 

Bottles of 100: NDC 65162-442-10

 

 

Bottles of 500: NDC 65162-442-50

 

 

Bottles of 1000: NDC 65162-442-11

 

 

Blister packs: NDC 65162-442-60

 

 

(Packages of 100 unit doses, 10 cards of 10 tablets each)

 

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:

Bottles of 30: NDC 65162-444-03

 

Bottles of 100: NDC 65162-444-10

 

 

Bottles of 500: NDC 65162-444-50

 

 

Bottles of 1000: NDC 65162-444-11

 

 

Blister packs: NDC 65162-444-60

 

 

(Packages of 100 unit doses, 10 cards of 10 tablets each)

 

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

Dispense in a tight, light-resistant container.

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY  11788

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 12-2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL