2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister pack. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Norgestimate and Ethinyl Estradiol Tablets USP Norgestimate and Ethinyl Estradiol Tablets USP are dispensed in a blister pack [see How Supplied/Storage and Handling ( 16 )]. Norgestimate and Ethinyl Estradiol Tablets USP may be started using either a Day 1 start or a Sunday start (see Table 1 ). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Norgestimate and Ethinyl Estradiol Tablets USP Table 1: Instructions for Administration of Norgestimate and Ethinyl Estradiol Tablets USP Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) active tablets are dark blue (Day 1 to Day 21). Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) active tablets are light blue (Day 1 to Day 7), medium blue (Day 8 to Day 15) and dark blue (Day 16 to Day 21). Norgestimate and Ethinyl Estradiol Tablets USP both have white inactive tablets (Day 22 to Day 28). Day 1 Start: Take first active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one white inactive tablet daily for 7 days and at the same time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start: Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Norgestimate and Ethinyl Estradiol Tablets USP. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one white inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Norgestimate and Ethinyl Estradiol Tablets USP from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Norgestimate and Ethinyl Estradiol Tablets USP Start Norgestimate and Ethinyl Estradiol Tablets USP: Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting Norgestimate and Ethinyl Estradiol Tablets USP after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Norgestimate and Ethinyl Estradiol Tablets USP may be started immediately. An additional method of contraception is not needed if Norgestimate and Ethinyl Estradiol Tablets USP are started immediately. If Norgestimate and Ethinyl Estradiol Tablets USP are not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Norgestimate and Ethinyl Estradiol Tablets USP. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Norgestimate and Ethinyl Estradiol Tablets USP, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Norgestimate and Ethinyl Estradiol Tablets USP. [See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and FDA-Approved Patient Labeling .] Starting Norgestimate and Ethinyl Estradiol Tablets USP after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Norgestimate and Ethinyl Estradiol Tablets USP following the instructions in Table 1 for women not currently using hormonal contraception. Norgestimate and Ethinyl Estradiol Tablets USP are not recommended for use in lactating women [see Use in Specific Populations ( 8.3 )]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Norgestimate and Ethinyl Estradiol Tablets USP. [See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 and 8.3 ), and FDA-Approved Patient Labeling ]. BEFORE YOU START TAKING YOUR PILLS, SET THE DAY: Day 1 Start: Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even it is almost midnight when the bleeding begins). Place this day label strip on the tablet blister card over the area that has the days of the week (starting with Sunday) printed on the blister. Take the tablets in the direction of the arrows in the picture (from left to right) each week. For Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg), take the first light blue “active” tablet during the first 24 hours of your period that corresponds with the day of the week the first tablet will be taken. For Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg), take the first dark blue “active” tablet during the first 24 hours of your period that corresponds with the day of the week the first tablet will be taken. Sunday Start: Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) - the first light blue “active” tablet should be taken on the first Sunday after the patient's menstrual period begins. If your period begins on Sunday, start the pack that same day. Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) - the first dark blue “active” tablet should be taken on the first Sunday after the patient's menstrual period begins. If your period begins on Sunday, start the pack that same day. Figure 2.3 Missed Tablets Table 2: Instructions for Missed Norgestimate and Ethinyl Estradiol Tablets USP If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday. then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling ]. 2.5 Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) Use for Acne The timing of initiation of dosing with Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) for acne should follow the guidelines for use of Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section ( 2.1 ) for instructions.