MECLIZINE HYDROCHLORIDE Tablet Ref.[10835] Active ingredients: Meclozine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder.

It has the following structural formula:

Chemically, meclizine hydrochloride 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. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake.

Dosage Forms and Strengths
  • 12.5 mg, blue, modified oval-shaped tablets, de-bossed with “Є12” on one side and plain on the other side.
  • 25 mg, white, modified oval-shaped tablets, de-bossed with “Є14” on one side, and plain on the other side.
How Supplied

Meclizine Hydrochloride Tablets, USP are available as follows:

12.5 mg, blue, modified oval-shaped tablets, de-bossed with “Є12” on one side, and plain on the other side. They are supplied as follows:

NDC 42806-012-01 in bottles of 100
NDC 42806-012-10 in bottles of 1000

25 mg, white, modified oval-shaped tablets, de-bossed with “Є14” on one side, and plain on the other side. They are supplied as follows:

NDC 42806-014-01 in bottles of 100
NDC 42806-014-10 in bottles of 1000

Distributed by: Epic Pharma, LLC, Laurelton, NY 11413

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