Diclofenac Potassium: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 50 mg

NDC 0378-2474-01

Diclofenac
Potassium
Tablets, USP
50 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 100 Tablets

Each film-coated tablet
contains: Diclofenac
potassium, USP 50 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com RM2474A5

DICLOFENAC POTASSIUM diclofenac potassium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-2474 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC POTASSIUM (DICLOFENAC) DICLOFENAC POTASSIUM 50 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE CROSCARMELLOSE SODIUM TRIACETIN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code M;D5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-2474-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075463 09/17/1999 02/29/2024

Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 10/2020 Mylan Pharmaceuticals Inc.