Ultram - Indications & Dosage

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HOW SUPPLIED

ULTRAM (tramadol hydrochloride tablets) Tablets Ð 50 mg (white, scored, film-coated capsule-shaped tablet) debossed "ULTRAM" on one side and "06 59" on the other side.

100's Ð NDC 0045-0659-60 bottles of 100 tablets

500's Ð NDC 0045-0659-70 bottles of 500 tablets

Packages of 100 unit doses in blister packs Ð NDC 0045-0659-10 (10 cards of 10 tablets each).

Dispense in a tight container. Store at 25° C (77° F); excursions permitted to 15 -30° C (59 -86° F).

OMP DIVISION ORTHO-McNEIL PHARMACEUTICAL, INC.

Raritan, New Jersey 08869

U. S. Patents 3,652,589 and 3,830,934 © OMP 2001 Revised August 2001 7517003

Up to Up to Up to 7 Days 30 Days 90 Days

Dizziness/ Vertigo 26% 31% 33% Nausea 24% 34% 40%

Constipation 24% 38% 46% Headache 18% 26% 32%

Somnolence 16% 23% 25% Vomiting 9% 13% 17%

Pruritus 8% 10% 11% "CNS Stimulation" 1 7% 11% 14%

Asthenia 6% 11% 12% Sweating 6% 7% 9%

Dyspepsia 5% 9% 13% Dry Mouth 5% 9% 10%

Diarrhea 5% 6% 10%