Vioxx

[Rofecoxib]

* adverse experience that resulted in death, permanent or substantial disability, hospitalization, congenital anomaly, or cancer, was immediately life threatening, was due to an overdose, or was thought by the investigator to require intervention to prevent one of the above outcomes

VIOXX (rofecoxib tablets and oral suspension) 9556413

HOW SUPPLIED

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No. 3810 - Tablets VIOXX, 12.5 mg, are cream/ off-white, round, shallow cup tablets engraved MRK 74 on one side and VIOXX on the other. They are supplied as follows:

NDC 0006-0074-31 unit of use bottles of 30
NDC 0006-0074-28 unit dose packages of 100
NDC 0006-0074-68 bottles of 100
NDC 0006-0074-82 bottles of 1000
NDC 0006-0074-80 bottles of 8000. No. 3834 - Tablets VIOXX, 25 mg, are yellow, round tablets engraved MRK 110 on one side and

VIOXX on the other. They are supplied as follows:
NDC 0006-0110-31 unit of use bottles of 30
NDC 0006-0110-28 unit dose packages of 100
NDC 0006-0110-68 bottles of 100
NDC 0006-0110-82 bottles of 1000
NDC 0006-0110-80 bottles of 8000. No. 3835 - Tablets VIOXX, 50 mg, are orange, round tablets engraved MRK 114 on one side and

VIOXX on the other. They are supplied as follows:
NDC 0006-0114-31 unit of use bottles of 30
NDC 0006-0114-28 unit dose packages of 100
NDC 0006-0114-68 bottles of 100
NDC 0006-0114-74 bottles of 500
NDC 0006-0114-81 bottles of 4000. No. 3784 - Oral Suspension VIOXX, 12.5 mg/ 5 mL, is an opaque, white to faint yellow suspension

with a strawberry flavor that is easily resuspended upon shaking.
NDC 0006-3784-64 unit of use bottles containing 150 mL (12.5 mg/ 5 mL). No. 3785 - Oral Suspension VIOXX, 25 mg/ 5 mL, is an opaque, white to faint yellow suspension with a strawberry flavor that is easily resuspended upon shaking.
NDC 0006-3785-64 unit of use bottles containing 150 mL (25 mg/ 5 mL).

Storage
VIOXX Tablets:
Store at 25° C (77° F), excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature.]

VIOXX Oral Suspension:
Store at 25° C (77° F), excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature.]

Rx only

Issued August 2003 Printed in USA

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