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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

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 a "50" in the middle on one side and "G" and "0028" on the other.
  • 75 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with a "75" in the middle on one side and "G" and "0029" on the other.

The dosage strengths are supplied in:

StrengthNDC NumberSize
Diclofenac sodium/misoprostol 5050 mg diclofenac sodium
and
200 mcg misoprostol
59762-0028-1bottle of 60
59762-0028-2bottle of 90
Diclofenac sodium/misoprostol 7575 mg diclofenac sodium
and
200 mcg misoprostol
59762-0029-1bottle 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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