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 Tablets 50 mg Bottle Label
(click image for full-size original)
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.

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