Plan B One-Step description, usages, side effects, indications, overdosage, supplying and lots more!

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Plan B One-Step

Teva Women's Health, Inc.

Plan B One-Step Emergency ContraceptiveOne Tablet. One Step.What You Need to Know


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 .

Uses

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®.

How does Plan B One-Step work?

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).

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.

Other Information

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.

Do not use if the blister seal is opened.

Store at room temperature 20–25°C (68–77°F).

Active ingredient

Active ingredient: levonorgestrel 1.5 mg

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

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.

©2011 Teva Women’s Health, Inc.          799-33-100269          Rev.A Iss. 12/2011          

Printed in USA

Package Principal Display Panel – NDC 51285-943-88

Plan B One-Step

NDC 51285-943-88

 

New! Now Available Over the Counter

Plan B
One-Step®

levonorgestrel 1.5 mg

Emergency Contraceptive

Reduces the chance of pregnancy after unprotected sex.

Not for regular birth control.

Contains 1 Tablet 1.5mg

One Tablet.
One Step.

Plan B One-Step

levonorgestrel TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51285-943
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 Size Imprint Code Shape
WHITE 8 mm G00 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:51285-943-88 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021998 2013-07-08


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