Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy in women of reproductive age.

Ethinyl estradiol and norgestrel may also be used for purposes not listed in this medication guide.

Do not take birth control pills if you are pregnant or if you have recently had a baby.

You should not use birth control pills if you have: heart problems, coronary artery disease, circulation problems, undiagnosed vaginal bleeding, liver problems, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the birth control pills exactly as directed.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using birth control pills. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

Some birth control packs contain seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding. Tell your doctor if it continues or if it is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Contraception:

1 tablet orally once a day

Comments:
-To be taken at the same time each day.
-Correct and consistent use can result in low failure rates.
-Withdrawal bleeding usually occurs within 3 days after discontinuing active tablets.

Use: For the prevention of pregnancy in women who elect to use this product as a method of contraception

Usual Pediatric Dose for Contraception:

1 tablet orally once a day

Comments:
-To be taken at the same time each day.
-Correct and consistent use can result in low failure rates.
-Withdrawal bleeding usually occurs within 3 days after discontinuing active tablets.

Use: For the prevention of pregnancy in women who elect to use this product as a method of contraception

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take birth control pills if you smoke and are over 35 years old.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);

• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;

• circulation problems (especially if caused by diabetes);

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;

• unusual vaginal bleeding that has not been checked by a doctor;

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

• a history of jaundice caused by pregnancy or birth control pills;

• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; or

• liver disease or liver cancer.

Tell your doctor if you have or have ever had:

• depression;

• a condition called hereditary angioedema;

• jaundice (yellowing of the skin or eyes); or

• liver or kidney disease.

Do not use if you are pregnant. Stop using birth control pills and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

Ask a doctor if it is safe to breastfeed while using birth control pills.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take two pills on the day you remember. Then take one pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Using birth control pills will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Birth control pills may cause serious side effects. Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;

• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;

• depression--mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;

• swelling in your hands, ankles, or feet, or a breast lump; or

• changes in the pattern or severity of migraine headaches.

Common side effects of ethinyl estradiol and norgestrel may include:

• changes in weight or appetite, stomach pain, gas, nausea or vomiting;

• headache, nervousness, depression, fatigue;

• vaginal bleeding or spotting, breakthrough bleeding;

• acne, darkening of facial skin;

• worsening of varicose veins;

• breast tenderness or menstrual cramps; or

• cervical problems, vaginal itching, or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• St. John's wort;

• colesevelam;

• cholesterol lowering medicine such as atorvastatin, or rosuvastatin; or

• HIV or AIDS medicine such as ritonavir, nelfinavir, indinavir, nevirapine, etravirine, and others.

This list is not complete. Other drugs may affect ethinyl estradiol and norgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.