Warnings

Allergy alert

Do not use if you have ever had an allergic reaction to levonorgestrel.

Sexually transmitted diseases (STDs) alert

This product does not protect against HIV/AIDS or other STDs.

Do not use:

• If you are already pregnant (because it will not work).
• For regular birth control.

Interactions

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

Side Effects

When using this product you may have:

• Menstrual changes
• Tiredness
• Breast pain
• Nausea
• Headache
• Vomiting
• Lower stomach (abdominal) pain
• Dizziness

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Directions

• Take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
• If you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose.

Other information

• Read the instructions, warnings and enclosed product leaflet before use.
• Do not use if carton is open or tear strip is removed or blister seal is broken or missing.
• Store at 20-25°C (68-77°F).

Ingredients

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc.

Questions?

Call 1-800-330-1271 or visit www.PlanBOneStep.com.

Distributed by:
Foundation Consumer Healthcare, LLC. (FCH)
Pittsburgh, PA 15205

Consumer Information Leaflet

Frequently Asked Questions

What is Plan B One-Step?

Plan B One-Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.

What Plan B One-Step is not.

Plan B One-Step will not work if you are already pregnant and will not affect an existing pregnancy. Plan B One-Step will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use Plan B One-Step?

The sooner you take emergency contraception, the better it works. You should use Plan B One-Step within 72 hours (3 days) after you have had unprotected sex.

Plan B One-Step is a backup or emergency method of birth control you can use when:

• Your regular birth control was used incorrectly or failed.
• You did not use any birth control method.

When not to use Plan B One-Step.

Plan B One-Step should not be used:

• As a regular birth control method, because it’s not as effective as regular birth control.
• If you are already pregnant, because it will not work.
• If you are allergic to levonorgestrel or any other ingredients in Plan B One-Step.

When should I talk to a doctor or pharmacist?

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Plan B One-Step and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

How does Plan B One-Step work?

How does Plan B One-Step work? Plan B One-Step works before release of an egg from the ovary. As a result, Plan B One-Step usually stops or delays the release of an egg from the ovary. Plan B One-Step is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy.

How can I get the best results from Plan B One-Step?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Plan B One-Step®, the better it works.

How effective is Plan B One-Step?

If Plan B One-Step® is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know Plan B One-Step worked?

You will know Plan B One-Step has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

Will I experience any side effects?

• Some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.
• If you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
• When used as directed, Plan B One-Step is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
• If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

What if I still have questions about Plan B One-Step?

If you have questions or need more information, call our toll-free number, 1-800-330-1271, or visit our website at www.PlanBOneStep.com.

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-162-88

NDC 69536-162-88

This item is electronically protected

Plan B One-Step®

levonorgestrel 1.5 mg

emergency contraceptive

Reduces chance of pregnancy after unprotected sex. Not for regular birth control.

One Tablet. One Step.

1 Tablet Levonorgestrel 1.5 mg

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-146-19

FOR CLINIC USE ONLY. NOT FOR RESALE.

NDC 69536-146-19

Plan B
One-Step®

levonorgestrel 1.5 mg

emergency contraceptive

Reduces chance of pregnancy after unprotected sex.Not for regular birth control.

One Tablet. One Step.

1 Tablet Levonorgestrel 1.5 mg