Prescription Drug Information: MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE — meclizine hydrochloride tablet
STAT Rx USA LLC

DESCRIPTION

Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:

chemical structure
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C25 H27 CIN2 •2HCI•H2 O M.W. 481.89

The chemical name is 1-(p -chloro-alpha-phenylbenzyl)-4-(m -methyl-benzyl) — piperazine dihydrochloride monohydrate.

Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration.

*Contains FD&C Yellow #5 (see PRECAUTIONS).

Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5.

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 prevention and treatment of nausea, vomiting, or 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 the 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. Do not give to children under 12 years of age unless directed by a doctor.

PRECAUTIONS

The Meclizine Hydrochloride Tablets, 25 mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Usage in Children: Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended under 12 years of age.

Usage in Pregnancy: 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 meclizine hydrochloride 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 hydrochloride, 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 meclizine hydrochloride, 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 — blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots. They are supplied in:

Bottles of 30 NDC 16590-301-30

Bottles of 60 NDC 16590-301-60

Bottles of 90 NDC 16590-301-90

Meclizine Hydrochloride Tablets, USP 25 mg — yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied in:

Bottles of 14 NDC 16590-146-14

Bottles of 15 NDC 16590-146-15

Bottles of 20 NDC 16590-146-20

Bottles of 30 NDC 16590-146-30

Bottles of 40 NDC 16590-146-40

Bottles of 60 NDC 16590-146-60

Bottles of 90 NDC 16590-146-90

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

Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured by:

PAR PHARMACEUTICAL COMPANIES, INC.

Spring Valley, NY 10977

Revised: 11/09

OS034-01-1-11

Relabeling and Repackaging by:
STAT Rx USA LLC
Gainesville, GA

PACKAGE LABEL — MECLIZINE 12.5 MG TABLETS

MECLIZINE 12_5MG 16590-301 LABEL Image
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MECLIZINE 12_5MG 16590-301 LABEL Image

PACKAGE LABEL — MECLIZINE 25 MG TABLETS

MECLIZINE 25MG 16560-146  LABEL Image
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MECLIZINE 25MG 16560-146 LABEL Image
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-301(NDC:49884-034)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
WATER
ISOPROPYL ALCOHOL
FD&C BLUE NO. 1
MAGNESIUM STEARATE
COLLOIDAL SILICON DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 5mm
Flavor Imprint Code Par;034
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-301-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-301-60 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-301-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087127 06/03/1981
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-146(NDC:49884-035)
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
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
WATER
ISOPROPYL ALCOHOL
D&C YELLOW NO. 10
MAGNESIUM STEARATE
COLLOIDAL SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 6mm
Flavor Imprint Code Par;035
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-146-14 14 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-146-15 15 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-146-20 20 TABLET (TABLET) in 1 BOTTLE None
4 NDC:16590-146-30 30 TABLET (TABLET) in 1 BOTTLE None
5 NDC:16590-146-40 40 TABLET (TABLET) in 1 BOTTLE None
6 NDC:16590-146-60 60 TABLET (TABLET) in 1 BOTTLE None
7 NDC:16590-146-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087128 06/03/1981
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc. (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLC 786036330 relabel (16590-301), repack (16590-301), relabel (16590-146), repack (16590-146)

Revised: 09/2012 STAT Rx USA LLC

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