MY WAY- levonorgestrel tablet 
Lupin Pharmaceuticals,Inc.

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Drug Facts

Active Ingredient

Levonorgestrel 1.5mg

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

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, pregelatinized starch, lactose monohydrate, magnesium stearate and talc

Questions?

For more information or to speak to a healthcare professional, call 1-800-422-8689 or visit our website at www.mywaypill.com

My Way 

Emergency Contraceptive

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:

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 1-800-422-8689, or visit our website at www.mywaypill.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 20–25°C (68–77°F).

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and 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:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI6223000201

Rev. 02/2014

PRINCIPAL DISPLAY PANEL

My Way (levonorgestrel) Tablet , 1.5 mg

NDC 43386-622-30

emergency contraceptive

Reduces chance of pregnancy after unprotected sex.

Not for regular birth control.

Contains 1 Tablet 1.5mg

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MY WAY 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43386-622
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)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43386-622-301 in 1 CARTON; Type 0: Not a Combination Product02/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20250802/15/2013
Labeler - Lupin Pharmaceuticals,Inc. (089153071)
Registrant - GAVIS Pharmaceuticals, LLC (829838551)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories, Inc.793518643analysis(43386-622) , manufacture(43386-622)

Revised: 6/2016
Document Id: 6dce7821-019c-4344-9634-5a51060920d5
Set id: ec01077e-ac3c-424a-9edc-0854fe0a2e0d
Version: 3
Effective Time: 20160617
 
Lupin Pharmaceuticals,Inc.