ARTHROTEC® How Supplied/Storage and Handling

(misoprostol, diclofenac sodium)

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 50

50 mg diclofenac sodium
and
200 mcg misoprostol

0025-1411-60

bottle of 60

0025-1411-90

bottle of 90

ARTHROTEC 75

75 mg diclofenac sodium
and
200 mcg misoprostol

0025-1421-60

bottle 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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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 50

50 mg diclofenac sodium
and
200 mcg misoprostol

0025-1411-60

bottle of 60

0025-1411-90

bottle of 90

ARTHROTEC 75

75 mg diclofenac sodium
and
200 mcg misoprostol

0025-1421-60

bottle 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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