Fallback Solo is used to prevent pregnancy after unprotected sex or failure of other forms of birth control (such as condom breakage, or missing 2 or more birth control pills).

Fallback Solo may also be used for purposes not listed in this medication guide.

Fallback Solo will not terminate pregnancy if the fertilized egg has already attached to the uterus.

Ask a doctor or pharmacist before taking levonorgestrel if you regularly use medication for seizures, tuberculosis, or HIV/AIDS. Certain other medicines can make levonorgestrel less effective.

Use exactly as directed on the label, or as prescribed by your doctor.

Fallback Solo must be taken as soon as possible after unprotected sex (no later than 72 hours afterward).

Call your doctor right away if you vomit within 2 hours after taking Fallback Solo. Do not take a second dose without first asking your doctor.

If your period is late by 1 week or longer after the expected date, you may be pregnant. Get a pregnancy test and contact your doctor if you are pregnant. Fallback Solo will not terminate pregnancy if the fertilized egg has attached to the uterus.

Within 3 weeks after taking Fallback Solo, a doctor should confirm that you are not pregnant, and that this medicine has not caused any harmful effects.

Store at room temperature away from moisture and heat.

Fallback Solo is not intended for use as a routine form of birth control. Talk with your doctor about the many forms of birth control available.

Do not use this medicine if you are already pregnant. Fallback Solo will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Not approved for use by anyone younger than 17 years old.

You should not use levonorgestrel if you are allergic to it.

Ask a doctor or pharmacist before taking levonorgestrel if you regularly use medication for seizures, tuberculosis, or HIV/AIDS. Certain medications can make levonorgestrel less effective as an emergency form of contraception.

Levonorgestrel may slow breast milk production. Tell your doctor if you are breastfeeding.

Since Fallback Solo is used as a single dose, it does not have a daily dosing schedule.

Because Fallback Solo is supplied as a single tablet in an exact strength, an overdose is unlikely to occur when the levonorgestrel is used as directed. Do not take more than one tablet at the same time.

Fallback Solo will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. Avoid having unprotected sex.

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

Call your doctor or seek emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

Common side effects of Fallback Solo may include:

• stomach pain;

• breast pain or tenderness;

• nausea, vomiting, diarrhea;

• headache, dizziness;

• feeling tired; or

• changes in your menstrual periods.

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.

Certain other medications can make Fallback Solo less effective, which may result in pregnancy. Ask a doctor or pharmacist if Fallback Solo is safe to use if you are using any of the following medications:

• efavirenz;

• rifampin; or

• seizure medication--carbamazepine, felbamate, fosphenytoin, phenobarbital, phenytoin, primidone.

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