PLAN B ONE-STEP- levonorgestrel tablet 
A-S Medication Solutions

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Plan B One-Step®

Drug Facts

Active ingredient

Levonorgestrel 1.5 mg

Purpose

Emergency contraceptive

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

Do not use

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.

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

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

CONSUMER INFORMATION
Plan B One-Step®
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know
Plan B One-Step® Logo
Teva Women’s Health, Inc.

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?

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?

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: 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.

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©2017 Teva Women’s Health, Inc.

Rev. 7/2017 Printed in USA

levonorgestrel

Label Image
PLAN B ONE-STEP 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1141(NDC:51285-146)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, POTATO (UNII: 8I089SAH3T)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code G00
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-1141-01 in 1 BOX, UNIT-DOSE11/28/2014
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199812/18/2013
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1141)

Revised: 2/2021
Document Id: 39879d82-a7ee-467e-88cb-1134501e37b2
Set id: 5b7f49c5-8271-476d-9cbb-9f13e8a51f1d
Version: 7
Effective Time: 20210222
 
A-S Medication Solutions