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- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Quality Care Products LLC
MECLIZINE HYDROCHLORIDE
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Major Pharmaceuticals
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 DIRECT RX
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 A-S Medication Solutions
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 REMEDYREPACK INC.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 American Health Packaging
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 American Health Packaging
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 AvPAK
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 American Health Packaging
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Proficient Rx LP
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 NuCare Pharmaceuticals,Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 REMEDYREPACK INC.
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 NuCare Pharmaceuticals,Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 DIRECT RX
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 PD-Rx Pharmaceuticals, Inc.
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Quality Care Products LLC
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Amneal Pharmaceuticals LLC
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Northwind Pharmaceuticals, LLC
- Meclizine Hydrocloride MECLIZINE HYDROCHLORIDE 25 mg/1 QPharma Inc
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Asclemed USA, Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Rising Pharmaceuticals, Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 A-S Medication Solutions
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 AvPAK
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 ANI Pharmaceuticals, Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 AvKARE
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 JUBILANT CADISTA PHARMACEUTICALS INC.
- Meclizine hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Proficient Rx LP
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Northwind Pharmaceuticals, LLC
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Amneal Pharmaceuticals LLC
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Major Pharmaceuticals
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 REMEDYREPACK INC.
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 A-S Medication Solutions
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 RedPharm Drug, Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 A-S Medication Solutions
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 AvPAK
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 RPK Pharmaceuticals, Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Zydus Pharmaceuticals (USA) Inc.
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Proficient Rx LP
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Bryant Ranch Prepack
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Bryant Ranch Prepack
- Antivert MECLIZINE HYDROCHLORIDE 25 mg/1 Casper Pharma LLC
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 NuCare Pharmaceuticals,Inc.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Redpharm Drug, Inc.
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Denton Pharma, Inc. dba Northwind Pharmaceuticals
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 REMEDYREPACK INC.
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Bryant Ranch Prepack
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 American Health Packaging
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Proficient Rx LP
- MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25 mg/1 Aurobindo Pharma Limited
- Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE 25 mg/1 Zydus Lifesciences Limited
Summary of product characteristics
Adverse Reactions
ADVERSE REACTIONS Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
Contraindications
CONTRAINDICATIONS Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Description
DESCRIPTION Chemically, Meclizine HCl is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. C 25 H 27 ClN 2 . 2HCl . H 2 O 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%). Structure of Meclizine HCl
Dosage And Administration
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.
Indications And Usage
INDICATIONS AND USAGE For the management of nausea and vomiting, and dizziness associated with motion sickness.
Warnings
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.
Clinical Pharmacology
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.
Effective Time
20230626
Version
13
Spl Product Data Elements
MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride Meclizine Hydrochloride Meclizine Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Fd&c Blue No. 1 Aluminum Oxide TL122 MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride Meclizine Hydrochloride Meclizine Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline D&c Yellow No. 10 Aluminum Oxide TL121
Application Number
ANDA040659
Brand Name
MECLIZINE HYDROCHLORIDE
Generic Name
Meclizine Hydrocloride
Product Ndc
35356-914
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
Image of 12.5mg Label image description
How Supplied
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
Precautions
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.
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Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.