MY WAY - levonorgestrel tablet 
Lupin Pharmaceuticals, Inc.

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My Way®
(levonorgestrel) Tablet, 1.5 mg

Drug Facts

Active Ingredient

Levonorgestrel USP 1.5 mg

Purpose

Emergency contraceptive

Indications

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 the 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, corn starch, lactose monohydrate, magnesium stearate, and povidone.

Questions or comments?

For more information or to speak to a healthcare professional, call at 1-800-422-8689 M-F 8:00 am - 5:00 pm or visit our website at www.mywaypill.com.

My Way®

(levonorgestrel) Tablet, 1.5 mg

Emergency Contraceptive

One Tablet. One Dose.

What You Need to Know

What is My Way®?

My Way 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 My Way is not.

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

When should I use My Way?

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

My Way is a backup or emergency method of birth control you can use when:

When not to use My Way?

My Way 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 My Way 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 My Way work?

My Way is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. My Way 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 My Way 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 My Way?

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

How effective is My Way?

If My Way 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 My Way worked?

You will know My Way 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 My Way?

If you have questions or need more information, call at 1-800-422-8689 M-F 8:00 am - 5:00 pm or visit our website at www.mywaypill.com.

Other Information

Keep this and all medication 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 seal is opened.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Active Ingredient: levonorgestrel 1.5 mg

Inactive Ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

My Way® is a registered trademark of Lupin Pharmaceuticals, Inc.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) - 454 775

INDIA

Revised: October 2017                                                                                               ID#: 253401

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

My Way®(levonorgestrel) Tablet, 1.5 mg

NDC 68180-852-11

Single Pack-  Carton Label: 1 blister containing 1 Tablet

single pack carton
MY WAY 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68180-852
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeROUND (round biconvex) Size9mm
FlavorImprint Code LU;S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68180-852-111 in 1 CARTON04/25/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68180-852-122 in 1 PACKAGE04/25/201705/03/2019
21 in 1 CARTON
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20144604/25/2017
Labeler - Lupin Pharmaceuticals, Inc. (089153071)
Registrant - LUPIN LIMITED (675923163)
Establishment
NameAddressID/FEIBusiness Operations
LUPIN LIMITED650582310MANUFACTURE(68180-852) , PACK(68180-852)

Revised: 12/2021
Document Id: 0f6cd732-80a5-4a08-92cf-f82df68df00c
Set id: 3efec61d-e0a6-49c5-9b88-834db6d171fd
Version: 5
Effective Time: 20211210
 
Lupin Pharmaceuticals, Inc.