MECLIZINE HYDROCHLORIDE TABLETS, USPRx only

MECLIZINE HYDROCHLORIDE TABLETS, USPRx only

Drug Labeling and Warnings

Drug Details

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MECLIZINE HYDROCHLORIDE - meclizine hydrochloride tablet 
Lake Erie Medical DBA Quality Care Products LLC

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MECLIZINE HYDROCHLORIDE TABLETS, USP
Rx only

DESCRIPTION

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

Structure of Meclizine HCl

                          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

image description

image description

MECLIZINE HYDROCHLORIDE  
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 35356-901(NDC: 59746-122)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570) Meclizine Hydrochloride12.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code TL122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35356-901-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201310/11/2019
2NDC: 35356-901-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201310/11/2019
3NDC: 35356-901-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201310/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04065906/04/201010/11/2019
MECLIZINE HYDROCHLORIDE  
meclizine hydrocloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 35356-914(NDC: 59746-121)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570) Meclizine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code TL121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35356-914-2020 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201306/01/2018
2NDC: 35356-914-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2013
3NDC: 35356-914-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201310/11/2019
4NDC: 35356-914-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201310/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04065906/04/2010
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(35356-901, 35356-914)

Revised: 10/2019
 
Lake Erie Medical DBA Quality Care Products LLC


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