Ortho Tri-Cyclen

[Noregestimate/Ethinyl Estradiol]

DOSAGE AND ADMINISTRATION

ORAL CONTRACEPTION

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To achieve maximum contraceptive effectiveness, ORTHO TRI-CYCLEN Tablets and ORTHO-CYCLEN Tablets must be taken exactly as directed and at intervals not exceeding 24 hours.

ORTHO TRI-CYCLEN and ORTHO-CYCLEN are available in the DIALPAK ® Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided. 28-Day Regimen (Sunday Start) When taking ORTHO TRI-CYCLEN 28 and ORTHO-CYCLEN 28 the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one green tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill" section).

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