ORTHO TRI-CYCLEN:

ORTHO TRI-CYCLEN Tablets are available in blister cards. Each blister card contains 28 tablets 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
4 CONTRAINDICATIONS
Do not prescribe ORTHO-CYCLEN or ORTHO TRI-CYCLEN to women who are known to have the following conditions:
A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
Have cerebrovascular disease [see Warnings and Precautions (5.1)]
Have coronary artery disease [see Warnings and Precautions (5.1)]
Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
Have uncontrolled hypertension [see Warnings and Precautions (5.3)]
Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5)]
Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.6)]
Women over age 35 with any migraine headaches [see Warnings and Precautions (5.6)]
Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7)]
Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)]
Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.10)]
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Disorders and Other Vascular ProblemsStop ORTHO-CYCLEN or ORTHO TRI-CYCLEN if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop ORTHO-CYCLEN or ORTHO TRI-CYCLEN if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. eva luate for retinal vein thrombosis immediately [see Adverse Reactions (6.2)].
If feasible, stop ORTHO-CYCLEN or ORTHO TRI-CYCLEN at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.
Start ORTHO-CYCLEN or ORTHO TRI-CYCLEN no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpa