Levonorgestrel by GLENMARK THERAPEUTICS INC., USA / Glenmark Pharmaceuticals Limited LEVONORGESTREL tablet

Levonorgestrel by

Drug Labeling and Warnings

Levonorgestrel by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, Glenmark Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Levonorgestrel, USP 1.5mg

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 disease (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 DOCTOR/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 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
• 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)

Inactive ingredients

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

Questions or comments?

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

Levonorgestrel Tablet 1.5 mgEmergency ContraceptiveOne Tablet, One DoseWhat You Need to Know

What is Levonorgestrel Tablet?

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.

What Levonorgestrel Tablet is not.

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).

When should I use Levonorgestrel Tablet?

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

When not to use Levonorgestrel Tablet.

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.

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 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.

How does Levonorgestrel Tablet work?

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.

How can I get the best results from Levonorgestrel Tablet?

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.

How effective is Levonorgestrel Tablet?

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.

How will I know Levonorgestrel Tablet worked?

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.

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, 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.

What if I still have questions about Levonorgestrel Tablet?

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.

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°C to 25°C (68°F to 77°F).

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

LEVONORGESTREL 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-123
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, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	G;78
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-123-11	1 in 1 CARTON	02/09/2023
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
ANDA	ANDA207044	02/09/2023

Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)

Establishment
Name	Address	ID/FEI	Business Operations
Glenmark Pharmaceuticals Limited		677318665	MANUFACTURE(72657-123) , ANALYSIS(72657-123)