21 Ethinyl Estradiol 0.035 MG norgestimate 0.25 MG Oral Tablet 7 Inert Ingredients 1 MG Oral Tablet Pack OrthoCyclen 28 Day
1 INDICATIONS AND USAGE ORTHO-CYCLEN and ORTHO TRI-CYCLEN are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14) ] .
Janssen Pharmaceuticals, Inc.
ROUND GREEN O M P
O M P ROUND GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ORTHO-CYCLEN ® ORTHO-CYCLEN ® Tablets are available in a single pouch containing a VERIDATE ® blister card (refill) of 28 tablets (NDC 50458-197-28). ORTHO-CYCLEN Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet Dispensers (NDC 50458-197-06). Each blister card (28 tablets) contains in the following order: 21 blue, round, biconvex, coated tablet imprinted "O 250" on one side and "35" on the other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 dark green round, biconvex, coated tablet (non-hormonal placebo) imprinted "O-M" on one side and "P" on the other side contains inert ingredients ORTHO-CYCLEN Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-197-20 and NDC 50458-197-12). ORTHO-CYCLEN Tablets are available in a DIALPAK ® Tablet Dispenser (unfilled) and DIALPAK refills (NDC 50458-197-00 and NDC 50458-197-15). ORTHO TRI-CYCLEN ® ORTHO TRI-CYCLEN ® Tablets are available in a single pouch containing a VERIDATE blister card (refill) of 28 tablets (NDC 50458-191-28). ORTHO TRI-CYCLEN Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet dispensers (NDC 50458-191-06). Each blister card (28 tablets) contains in the following order: 7 white, round, biconvex, coated tablet imprinted "O 180" on one side and "35" on the other side of the tablet contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol 7 light blue, round, biconvex, coated tablet imprinted "O 215" on one side and "35" on the other side of the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 7 blue, round, biconvex, coated tablet imprinted "O 250" on one side and "35" on the other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 dark green round, biconvex, coated tablet (non-hormonal placebo) imprinted "O-M" on one side and "P" on the other side contains inert ingredients ORTHO TRI-CYCLEN Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-191-20 and NDC 50458-191-12). ORTHO TRI-CYCLEN Tablets are available in a DIALPAK Tablet Dispenser (unfilled) and DIALPAK refills (NDC 50458-191-00 and NDC 50458-191-15). 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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