ortho tri cyclen lo norgestimate and ethinyl estradiol kit
1 INDICATIONS AND USAGE ORTHO TRI-CYCLEN Lo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception ORTHO TRI-CYCLEN Lo Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] .
janssen pharmaceuticals, inc.
ROUND BLUE O M 215
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ORTHO TRI-CYCLEN Lo Tablets are available in a single pouch containing a VERIDATE blister card (refill) of 28 tablets: NDC 50458-251-28. ORTHO TRI-CYCLEN Lo Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet Dispensers: NDC 50458-251-06 Each blister card (28 tablets) contains in the following order: 7 white, round, biconvex, coated tablets (active) imprinted "O-M" on one side and "180" on the other side contains 0.180 mg, norgestimate and 0.025 mg ethinyl estradiol 7 light blue, round, biconvex, coated tablets (active) imprinted "O-M" on one side and "215" on the other side contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 7 dark blue, round, biconvex, coated tablets (active) imprinted "O-M" on one side and "250" on the other side contains 0.250 mg norgestimate and 0.025 mg ethinyl estradiol 7 dark green, round, biconvex, coated tablets (non-hormonal placebo) imprinted "O-M" on one side and "P" on the other side contains inert ingredients ORTHO TRI-CYCLEN Lo Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills: NDC 50458-251-20 and NDC 50458-251-12 ORTHO TRI-CYCLEN Lo Tablets are available in a DIALPAK Tablet Dispenser (unfilled) and DIALPAK refills: NDC 50458-251-00 and NDC 50458-251-15 16.2 Storage Conditions Store at 20–25°C (68–77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Keep out of the reach of children.
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