MECLIZINE HYDROCHLORIDE tablet

MECLIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

MECLIZINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by STAT Rx USA LLC, PSS World Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

C25H27CIN22HCIH2O 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

PACKAGE LABEL - MECLIZINE 25 MG TABLETS

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	Par;034
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16590-301-30	30 in 1 BOTTLE
2	NDC: 16590-301-60	60 in 1 BOTTLE
3	NDC: 16590-301-90	90 in 1 BOTTLE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	6mm
Flavor		Imprint Code	Par;035
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16590-146-14	14 in 1 BOTTLE
2	NDC: 16590-146-15	15 in 1 BOTTLE
3	NDC: 16590-146-20	20 in 1 BOTTLE
4	NDC: 16590-146-30	30 in 1 BOTTLE
5	NDC: 16590-146-40	40 in 1 BOTTLE
6	NDC: 16590-146-60	60 in 1 BOTTLE
7	NDC: 16590-146-90	90 in 1 BOTTLE

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	Business Operations
STAT Rx USA LLC		786036330	relabel(16590-301, 16590-146) , repack(16590-301, 16590-146)