This medication is used to prevent pregnancy. It contains the hormone norgestrel (a progestin). It works by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization). It may also prevent the release of an egg (ovulation) during some menstrual cycles.

This medication is not an emergency contraceptive and will not prevent pregnancy when used after unprotected sex. Using this medication will not stop an existing pregnancy.

This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

If you are using the over-the-counter product to self-treat, read all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed.

Take this medication by mouth with or without food, once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.

It is very important to keep taking this medication exactly as directed on the product package. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.

If you have vomiting or diarrhea within 4 hours after taking your tablet, follow the directions in the product package for what to do if you miss a dose and use a backup form of birth control (such as condoms, spermicide) for 48 hours.

Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart.

Keep taking one tablet every day. After taking the last tablet in your existing pack, start a new pack the next day. Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods. Do not stop taking your pills if this happens.

If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (such as patch, other birth control pills), use a backup form of non-hormonal birth control (such as condoms, spermicide) for the first 48 hours to prevent pregnancy until the medication has enough time to work.

Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as patch, other birth control pills) to this product. If any information is unclear, consult the package instructions or your doctor or pharmacist.

See also How to Use section.

Nausea, vomiting, increased appetite, stomach cramping/bloating, dizziness, or headache may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), take a pregnancy test or contact your doctor.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• lumps in the breast
• mental/mood changes (such as new/worsening depression)
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding)

Get medical help right away if you have any very serious side effects, including:

• severe pain/discomfort in the abdomen/groin
• loss of appetite
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking norgestrel, tell your doctor or pharmacist if you are allergic to it; or to other progestins (such as norethindrone); or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this medication:

• abnormal breast exam
• cancer (especially breast cancer)
• diabetes
• depression
• severe headaches/migraines
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• liver disease (including tumors)
• unexplained vaginal bleeding

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss or abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control, such as this medication.

A small amount of this medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• acitretin
• alitretinoin
• isotretinoin
• ulipristal

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use reliable backup birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea and vomiting, sudden/unusual vaginal bleeding.

Keep all medical and lab appointments.

Refer to the product package information for advice on missed doses. You may need to use backup birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.