Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Meclizine Hydrochloride Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: 10 Tablets per card, 5 cards per carton: NDC 50268-522-15 Meclizine Hydrochloride Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: 10 Tablets per card, 5 cards per carton: NDC 50268-523-15 Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 2
- HOW SUPPLIED Meclizine Hydrochloride Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: 10 Tablets per card, 5 cards per carton: NDC 50268-522-15 Meclizine Hydrochloride Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: 10 Tablets per card, 5 cards per carton: NDC 50268-523-15 Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 2
Overview
Chemically, meclizinehydrochloride, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake. Image1
Indications & Usage
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.
Dosage & Administration
For the treatment of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 mg to 100 mg daily, 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 is 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 AvKARE at 1-855-361-3993; email [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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