Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 10 NDC 63187-996-10 Bottles of 20 NDC 63187-996-20 Bottles of 30 NDC 63187-996-30 Bottles of 60 NDC 63187-996-60 Bottles of 90 NDC 63187-996-90 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised 03/11; PRINCIPAL DISPLAY PANEL NDC 63187-996-20 Meclizine Hydrochloride Tablets, USP 25 mg 20 Tablets Rx Only Each tablet Contains 25 mg of meclizine HCl DOSAGE AND USE See accompanying prescribing information MOTION SICKNESS: 25 mg to 50 mg daily. Dispense in tight, light-resistant containers (USP). Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. 63187-996-20
- HOW SUPPLIED Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 10 NDC 63187-996-10 Bottles of 20 NDC 63187-996-20 Bottles of 30 NDC 63187-996-30 Bottles of 60 NDC 63187-996-60 Bottles of 90 NDC 63187-996-90 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised 03/11
- PRINCIPAL DISPLAY PANEL NDC 63187-996-20 Meclizine Hydrochloride Tablets, USP 25 mg 20 Tablets Rx Only Each tablet Contains 25 mg of meclizine HCl DOSAGE AND USE See accompanying prescribing information MOTION SICKNESS: 25 mg to 50 mg daily. Dispense in tight, light-resistant containers (USP). Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. 63187-996-20
Overview
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
Indications & Usage
For the management of nausea and vomiting, and dizziness associated with motion sickness.
Dosage & 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.
Warnings & Precautions
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.
Contraindications
Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Adverse Reactions
Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
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