Label: PLAN B ONE-STEP- levonorgestrel tablet

  • NDC Code(s): 51285-124-88, 51285-146-19, 51285-162-88
  • Packager: Teva Women's Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 17, 2018

If you are a consumer or patient please visit this version.

  • 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

    • 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.

  • When using this product you may have

    • menstrual changes
    • nausea
    • lower stomach (abdominal) pain
    • tiredness
    • headache
    • dizziness
    • breast pain
    • vomiting
  • 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
    • 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

  • Questions?

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

  • CONSUMER INFORMATIONPlan B One-Step® Emergency ContraceptiveOne Tablet. One Step.What You Need to KnowPlan B One-Step® LogoTeva 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:

    • 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?

    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: 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

  • Principal Display Panel, Part 1 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 1 of 3
  • Principal Display Panel, Part 2 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 2 of 3
  • Principal Display Panel, Part 3 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 3 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box Text

    NDC 51285-124-88

    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.

    Contains 1 Tablet 1.5mg

  • Principal Display Panel, Part 1 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box, Part 1 of 3
  • Principal Display Panel, Part 2 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box, Part 2 of 3
  • Principal Display Panel, Part 3 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box, Part 3 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box Text

    FOR CLINIC USE ONLY.

    NDC 51285-146-19

    See New Warning

    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 1.5mg

  • Principal Display Panel, Part 1 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 1 of 3
  • Principal Display Panel, Part 2 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 2 of 3
  • Principal Display Panel, Part 3 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 3 of 3

    Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box Text

    See New Warning

    NDC 51285-162-88

    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 1.5mg

  • INGREDIENTS AND APPEARANCE
    PLAN B ONE-STEP 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51285-124
    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:51285-124-881 in 1 BOX, UNIT-DOSE11/01/201306/30/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199811/01/201306/30/2017
    PLAN B ONE-STEP 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:51285-146-191 in 1 BOX, UNIT-DOSE12/18/201303/31/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199812/18/201303/31/2021
    PLAN B ONE-STEP 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51285-162
    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:51285-162-881 in 1 BOX, UNIT-DOSE08/26/201303/31/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199808/26/201303/31/2021
    Labeler - Teva Women's Health, Inc. (017038951)