Plan B One-step®

Plan B One-step®
SPL v4
SPL
SPL Set ID 716af323-e746-456a-9f74-6f46cab4b4bf
Route
ORAL
Published
Effective Date 2018-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Potato Magnesium Stearate Talc Starch, Corn Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: G00 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
NDA Active Since 2013-12-18

Description

Levonorgestrel 1.5 mg

Purpose

Emergency contraceptive


Medication Information

Purpose

Emergency contraceptive

Description

Levonorgestrel 1.5 mg

Use

for women 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

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
Do Not Use
  • if you are already pregnant (because it will not work)
  • for regular birth control

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.

Questions?

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

Plan B One Step
Active Ingredient

Levonorgestrel 1.5 mg

Other Information
  • read the instructions, warnings and enclosed product leaflet before use
  • this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
  • do not use if carton is open or tear strip is removed or blister seal is broken or missing.
  • store at 20-25ºC (68-77ºF)
Inactive Ingredients

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

What Plan B One Step®

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).

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.

How Does Plan B One Step®

Plan B One-Step® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Plan B One-Step® contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B One-Step® may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

Keep Out of Reach of Children.

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

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How Will I Know Plan B One Step®

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.

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®.
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.

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
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.
When Using This Product You May Have
  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headache
  • dizziness
  • breast pain
  • vomiting
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.

Store At Room Temperature 20–25°c (68–77°f).

Active ingredient: levonorgestrel 1.5 mg

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

  •  
    1-800-330-1271 www.PlanBOneStep.com

If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

  •  
    Manufacturer logo lock up PBOS logo lock up

©2017 Teva Women’s Health, Inc.

  •  
    Rev. 7/2017 Printed in USA
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.

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.


Structured Label Content

Use

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Purpose

Emergency contraceptive

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

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
Do Not Use (Do not use)
  • if you are already pregnant (because it will not work)
  • for regular birth control

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.

Questions?

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

Plan B One Step (Plan B One-Step)
Active Ingredient (Active ingredient)

Levonorgestrel 1.5 mg

Other Information (Other information)
  • read the instructions, warnings and enclosed product leaflet before use
  • this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
  • do not use if carton is open or tear strip is removed or blister seal is broken or missing.
  • store at 20-25ºC (68-77ºF)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

What Plan B One Step® (What Plan B One-Step®)

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).

What Is Plan B One Step® (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.

How Does Plan B One Step® (How does Plan B One-Step®)

Plan B One-Step® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Plan B One-Step® contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B One-Step® may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Keep Out of Reach of Children: (Keep out of reach of children:)

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How Will I Know Plan B One Step® (How will I know Plan B One-Step®)

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.

When Not to Use Plan B One Step® (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®.
How Effective Is Plan B One Step® (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.

When Should I Use Plan B One Step® (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
Will I Experience Any Side Effects? (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.
When Using This Product You May Have (When using this product you may have)
  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headache
  • dizziness
  • breast pain
  • vomiting
When Should I Talk to A Doctor Or Pharmacist? (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.

Store At Room Temperature 20–25°c (68–77°f). (Store at room temperature 20–25°C (68–77°F).)

Active ingredient: levonorgestrel 1.5 mg

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

  •  
    1-800-330-1271 www.PlanBOneStep.com

If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

  •  
    Manufacturer logo lock up PBOS logo lock up

©2017 Teva Women’s Health, Inc.

  •  
    Rev. 7/2017 Printed in USA
How Can I Get the Best Results From Plan B One Step® (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.

What If I Still Have Questions About Plan B One Step® (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.


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