When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to norethindrone, ethinyl estradiol, or ferrous fumarate, if you are pregnant, or if you have vaginal bleeding that has not been checked by a doctor, liver disease or tumors, breast cancer, problems with blood clots, or certain heart problems.

How to Use This Medicine:
Tablet, Chewable Tablet, Tablet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. .
• Take your pills at the same time every day in the order they appear in the container. Birth control pills work best when there is no more than 24 hours between doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Chewable tablets: The tablets may be chewed before swallowing, or swallowed whole. Drink a full glass of water immediately after you take the tablet.
• Use a second form of birth control for the first 7 days of your first cycle of pills. Your body will need at least 7 days to adjust to the new medicine before a pregnancy will be prevented.
• If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the patient instructions or call your doctor.
• Missed dose:
  
  • This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
  • Use a second form of birth control for the next 7 days after you miss a dose.
  • If you miss a pill or change your schedule, you may not have a period that month. Tell your doctor if you miss your period 2 months in a row, because you may be pregnant.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  
  • Acetaminophen, ascorbic acid (Vitamin C), atorvastatin, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, itraconazole, ketoconazole, lamotrigine, oxcarbazepine, phenytoin, rifampin, St John's wort, topiramate
  • Medicine for HIV/AIDS
  • Thyroid medicines

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have kidney disease, diabetes, gallbladder disease, hereditary angioedema, high blood pressure, high cholesterol, migraines, or a history of cervical cancer, depression, chloasma gravidarum, or jaundice during pregnancy. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Liver problems
  • High blood pressure
  • Gallbladder disease
  • Possible increased risk of cervical cancer
• You may need to stop using this medicine for a few weeks before and after surgery because of the risk of blood clots.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections.
• This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Heavy vaginal bleeding, irregular or missed menstrual period
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf), sudden or severe headache, or problems with vision, speech, or walking
• Vision loss, double vision

If you notice these less serious side effects, talk with your doctor:

• Breast tenderness or swelling
• Vaginal spotting or light bleeding, itching, or discharge

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088