Active Ingredient
Levonorgestrel, USP 1.5mg
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Levonorgestrel (NDC 73581-217). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, otc - ask doctor/pharmacist, when using this product you may have, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Levonorgestrel, USP 1.5mg
Emergency contraceptive
For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel
Sexually transmitted disease (STDs) alert: This product does not protect against HIV/AIDS or other STDs
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
The sooner you take it the better it will work.
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Levonorgestrel tablet 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.
Levonorgestrel tablet will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet within 72 hours (3 days)
after you have had unprotected sex
Levonorgestrel tablet is a backup or emergency method of birth control you can use when:
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 tablet and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.
Levonorgestrel tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel tablet 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 levonorgestrel tablet 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).
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. <content class="text-bold">The sooner you take levonorgestrel tablet, the better it works
If levonorgestrel tablet 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.
You will know levonorgestrel tablet 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.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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