Label: PLAN B ONE-STEP- levonorgestrel tablet
Contains inactivated NDC Code(s)
NDC Code(s): 76413-323-01
- Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 51285-146
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated April 26, 2018
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient
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
- Keep out of reach of children.
- 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
- 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®?
- What Plan B One-Step® is not.
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®.
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®?
- How effective is Plan B One-Step®?
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:
- 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
- Plan B One-Step
INGREDIENTS AND APPEARANCE
PLAN B ONE-STEP
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-323(NDC:51285-146) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code G00 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-323-01 1 in 1 CARTON 12/18/2013 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021998 12/18/2013 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Travis County Healthcare District 797039398 RELABEL(76413-323) , REPACK(76413-323)