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ARTHROTEC® (misoprostol, diclofenac sodium) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

ARTHROTEC (diclofenac sodium and misoprostol) delayed-release tablets are supplied as:

  • 50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with four "A's" encircling a "50" in the middle on one side and "SEARLE" and "1411" on the other.
  • 75 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with four "A's" encircling a "75" in the middle on one side and "SEARLE" and "1421" on the other.

The dosage strengths are supplied in:

StrengthNDC NumberSize
ARTHROTEC 5050 mg diclofenac sodium and 200 mcg misoprostol0025-1411-60bottle of 60
0025-1411-90bottle of 90
ARTHROTEC 7575 mg diclofenac sodium and 200 mcg misoprostol0025-1421-60bottle of 60

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

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