LEVONORGESTREL TABLET, 1.5 MG - levonorgestrel tablet, 1.5 mg tablet 
Strides Pharma Inc

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Levonorgestrel Tablet 1.5 mg

Active Ingredient

 Levonorgestrel 1.5 mg

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

Do not use

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.

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

Directions

Other information

Inactive ingredients

Colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions or comments?

Call 1-877-244-9825.

Manufactured for:

Strides Pharma Inc.

East Brunswick, NJ 08816

Product made in Germany

INFORMATION FOR PATIENTS

Levonorgestrel Tablet 1.5 mg

What is Levonorgestrel Tablet 1.5 mg?

Levonorgestrel Tablet 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.

What Levonorgestrel Tablet 1.5 mg is not.

Levonorgestrel Tablet 1.5 mg will not work if you are already pregnant and will not affect an existing pregnancy. The Levonorgestrel Tablet 1.5 mg will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use Levonorgestrel Tablet 1.5 mg?

The sooner you take emergency contraception, the better it works. You should use Levonorgestrel Tablet 1.5 mg within 72 hours (3 days) after you have had unprotected sex.

Levonorgestrel Tablet 1.5 mg is a backup or emergency method of birth control you can use when:

When not to use the Levonorgestrel Tablet 1.5 mg.

Levonorgestrel Tablet 1.5 mg should not be used:

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 1.5 mg 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 the Levonorgestrel Tablet 1.5 mg work?

Levonorgestrel Tablet 1.5 mg is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablet 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 Tablet 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).

How can I get the best results from Levonorgestrel Tablet 1.5 mg?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablet 1.5 mg, the better it works.

How effective is Levonorgestrel Tablet 1.5 mg?

If Levonorgestrel Tablet 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.

How will I know Levonorgestrel Tablet 1.5 mg worked?

You will know Levonorgestrel Tablet 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.

Will I experience any side effects?

What if I still have questions about Levonorgestrel Tablet 1.5 mg?

If you have questions or need more information, call our toll free number, 1-877-244-9825.

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° to 25°C (68° to 77°F).

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

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 for:

Strides Pharma Inc.

East Brunswick, NJ 08816

Product made in Germany.

 Issued: 09/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton label
LEVONORGESTREL TABLET, 1.5 MG 
levonorgestrel tablet, 1.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-282
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE (Light peach) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-282-011 in 1 CARTON09/13/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20238009/13/2022
Labeler - Strides Pharma Inc (078868278)
Registrant - Naari Pte. Limited (659345996)
Establishment
NameAddressID/FEIBusiness Operations
Haupt Pharma Muenster GmbH344172564ANALYSIS(59556-282) , MANUFACTURE(59556-282)

Revised: 9/2022
Document Id: 7a2ca863-fe8b-4ee6-9a63-40276db84b77
Set id: 98f6367e-14d2-4c7a-9418-d996f0040d22
Version: 1
Effective Time: 20220913
 
Strides Pharma Inc