MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

Drug Labeling and Warnings

Drug Details [pdf]

DESCRIPTION

Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

                          C25H27ClN2. 2HCl. H2O                                                                                        M.W. 481.88

Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).

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 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

PREGNANCY, Teratogenic Effects
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 medicine 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. 

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.

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 HCI 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 HCI Tablets, USP are available in the following strengths and package sizes:

12.5 mg (Blue, oval-shaped, scored, debossed with TL122)

NDC: 35356-901-30  Bottles of 30

NDC: 35356-901-60  Bottles of 60

NDC: 35356-901-90  Bottles of 90

25 mg (Yellow, oval-shaped, scored, debossed with TL121)

NDC: 35356-914-20  Bottles of 20

NDC: 35356-914-30  Bottles of 30

NDC: 35356-914-60  Bottles of 60

NDC: 35356-914-90  Bottles of 90

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

Manufactured By:

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.

Revised 03/11

Image of 12.5mg Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE  
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 35356-901(NDC:59746-122)
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
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Croscarmellose Sodium (UNII: M28OL1HH48)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Fd&c Blue No. 1 (UNII: H3R47K3TBD)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	TL122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35356-901-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	10/11/2019
2	NDC: 35356-901-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	10/11/2019
3	NDC: 35356-901-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	10/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040659	06/04/2010	10/11/2019

MECLIZINE HYDROCHLORIDE  
meclizine hydrocloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 35356-914(NDC:59746-121)
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
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Croscarmellose Sodium (UNII: M28OL1HH48)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
D&c Yellow No. 10 (UNII: 35SW5USQ3G)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	TL121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35356-914-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	06/01/2018
2	NDC: 35356-914-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013
3	NDC: 35356-914-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	10/11/2019
4	NDC: 35356-914-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013	10/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040659	06/04/2010

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(35356-901, 35356-914)