Levonorgestrel Tablet
FDA Label NDC 70700-164

Levonorgestrel 1.5 mg

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 diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

• 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.

In case of overdose, get medical help or contact a Poison Control center right away.

• 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

• 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 package is open or blister seal is broken or missing
• store levonorgestrel tablets 1.5 mg at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]

cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, poloxamer 188

Call 1-844-947-6633  Monday-Friday 9AM-5PM EST

Levonorgestrel tablets 1.5 mg 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 tablets 1.5 mg will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel tablets 1.5 mg 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 tablets 1.5 mg within 72 hours (3 days) after you have had unprotected sex.

Levonorgestrel tablets 1.5 mg 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

Levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg.

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 tablets 1.5 mg is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel tablets 1.5 mg 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 tablets 1.5 mg 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. The sooner you take levonorgestrel tablets 1.5 mg, the better it works.

If levonorgestrel tablets 1.5 mg 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 tablets 1.5 mg 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.

• 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, levonorgestrel tablets 1.5 mg 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.

If you have questions or need more information, call our toll-free number, 1-844-947-6633, or visit our website at www.xiromed.com.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Levonorgestrel Tablets
(levonorgestrel) tablets 1.5 mg
Emergency contraceptive
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.
Xiromed LLC.

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