Drug Catalog - Product Detail
Meclizine Hydrochloride 12.5mg Tablet 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0441-10 | AMNEAL PHARMACEUTICALS | 100 | 12.5MG | TABLET |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Chemically, meclizine HCl, 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. c89547bf-figure-01
How Supplied
HOW SUPPLIED Meclizine HCl 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: Bottles of 30: NDC 65162-441-03 Bottles of 100: NDC 65162-441-10 Bottles of 500: NDC 65162-441-50 Bottles of 1000: NDC 65162-441-11 Blister packs: NDC 65162-441-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine HCl 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: Bottles of 30: NDC 65162-442-03 Bottles of 100: NDC 65162-442-10 Bottles of 500: NDC 65162-442-50 Bottles of 1000: NDC 65162-442-11 Blister packs: NDC 65162-442-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine HCl 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. They are available as follows: Bottles of 30: NDC 65162-444-03 Bottles of 100: NDC 65162-444-10 Bottles of 500: NDC 65162-444-50 Bottles of 1000: NDC 65162-444-11 Blister packs: NDC 65162-444-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 01-2013
Indications & Usage
INDICATIONS AND USAGE Management of nausea and vomiting, and dizziness associated with motion sickness.
Dosage and Administration
DOSAGE AND ADMINISTRATION Motion Sickness The initial dose of 25 mg to 50 mg of meclizine HCl tablets, USP 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.