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Plan B One-Step Prescribing Information

Package insert / product label
Generic name: levonorgestrel emergency contraceptive [ LEE-voe-nor-jes-trel ]
Active ingredient: levonorgestrel 1.5 mg
Dosage form: tablet
Drug class: Contraceptives

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 22, 2023.

Use

Emergency contraceptive. Plan B One-Step is used to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control).

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:

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:

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

Directions

Other information

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:

When not to use Plan B One-Step.

Plan B One-Step should not be used:

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?

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

Plan B One-Step
levonorgestrel tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69536-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL LEVONORGESTREL 1.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, POTATO
MAGNESIUM STEARATE
TALC
STARCH, CORN
LACTOSE MONOHYDRATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code G00
Contains
Packaging
# Item Code Package Description
1 NDC:69536-162-88 1 BLISTER PACK in 1 BOX, UNIT-DOSE
1 1 TABLET in 1 BLISTER PACK
2 NDC:69536-162-99 1 BLISTER PACK in 1 BOX, UNIT-DOSE
2 1 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021998 05/10/2018
Plan B One-Step
levonorgestrel tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69536-146
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 1.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, POTATO
MAGNESIUM STEARATE
TALC
STARCH, CORN
LACTOSE MONOHYDRATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code G00
Contains
Packaging
# Item Code Package Description
1 NDC:69536-146-19 1 BLISTER PACK in 1 BOX, UNIT-DOSE
1 1 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021998 05/10/2018
Labeler - Foundation Consumer Healthcare LLC (079675882)
Foundation Consumer Healthcare LLC