MedPath
FDA Approval

CLEMASZ

May 3, 2025

HUMAN PRESCRIPTION DRUG LABEL

Clemastine(2.68 mg in 1 1)

Products (1)

CLEMASZ

84044-268

ANDA073283

ANDA (C73584)

ORAL

May 3, 2025

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: 19259EGQ3DClass: ACTIBQuantity: 2.68 mg in 1 1

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 2.68 mg Tablet Bottle Label

NDC 84044-268-03

Clemastine
Fumarate
Tablets, USP

2.68 mg

Rx only
30 Tablets

New HeightsRx, LLC.

PRINCIPAL DISPLAY PANEL - 2.68 mg Tablet Bottle Label


DESCRIPTION SECTION

DESCRIPTION

Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2 R)-2-[2-[[( R)- p-Chloro-α-methyl-α- phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1).

Chemical Structure

C 21H 26C1NO∙C 4H 4O 4

M.W. 459.97

Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP.

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid.


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