Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) NDC 60760-087-90 BOTTLES OF 90 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Keep this and all medication out of the reach of children. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised 01/2019; 087-90
- HOW SUPPLIED 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) NDC 60760-087-90 BOTTLES OF 90 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Keep this and all medication out of the reach of children. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised 01/2019
- 087-90
Overview
Meclizine HCl, USP an oral antiemetic, is a white or slightly yellowish, crystalline powder. It has the following structural formula: Chemically, Meclizine HCl is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine hydrochloride 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 hydrochloride tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine hydrochloride tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%). Each meclizine HCl 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine HCl 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Structure of Meclizine HCl
Indications & Usage
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.
Dosage & Administration
The recommended dose is 25 to 100 mg daily administered orally, in divided dosage, depending upon clinical response.
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 tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.
Adverse Reactions
Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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