GLENMARK THERAPEUTICS INC., USA Glenmark Pharmaceuticals Limited

Levonorgestrel Levonorgestrel LEVONORGESTREL LEVONORGESTREL SILICON DIOXIDE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, POTATO TALC off-white G;78

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

•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.

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

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 • do not use if carton is open or tear strip is removed or blister seal is broken or missing •Store at room temperature, 20°C to 25°C (68°F to 77°F)

Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

Call 1 (888) 721-7115 or visit www.glenmarkpharma-us.com

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: •your regular birth control was used incorrectly or failed •you did not use any birth control method

Levonorgestrel tablet 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 Tablet.

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 works before release of an egg from the ovary. As a result, levonorgestrel tablet usually stops or delays the release of an egg from the ovary. Levonorgestrel tablet is one tablet that contains a higher dose of levonorgestrel than the birth control pills and works in a similar way to prevent pregnancy.

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. 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.

•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 tablet 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 (888) 721-7115 or visit our website at www.glenmarkpharma-us.com.

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

Active ingredient: levonorgestrel, USP 1.5 mg Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc. 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. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Therapeutics Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com February 2023

carton