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 packaged in a carton (NDC 50458-197-15) containing 6 blister cards and 6 unfilled DIALPAK Tablet Dispensers.

ORTHO-CYCLEN Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-197-20 and NDC 50458-197-12).

ORTHO TRI-CYCLEN

ORTHO TRI-CYCLEN Tablets are available in a blister card with a DIALPAK Tablet Dispenser (unfilled): (NDC 50458-191-00)

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 packaged in a carton containing 6 blister cards and 6 unfilled DIALPAK Tablet dispensers: (NDC 50458-191-15)

ORTHO TRI-CYCLEN Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-191-20 and NDC 50458-191-12).

Keep out of reach of children.

16.2 Storage ConditionsStore at 20–25°C (68–77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Protect from light.
Close
17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Counsel patients about the following information:

Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning].
Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1)].
ORTHO-CYCLEN and ORTHO TRI-CYCLEN do not protect against HIV infection (AIDS) and other sexually transmitted infections.
ORTHO-CYCLEN and ORTHO TRI-CYCLEN are not to be used during pregnancy; if pregnancy occurs during use of ORTHO-CYCLEN or ORTHO TRI-CYCLEN instruct the patient to stop further use [see Warnings and Precautions (5.8)].
Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed [see Dosage and Administration (2.2)].
Use a back-up or alternative method of contraception when enzyme inducers are used with ORTHO-CYCLEN or ORT