ECONTRA EZ- levonorgestrel tablet 
Afaxys Pharma, LLC

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EContra® EZ
(Levonorgestrel) Tablet, 1.5 mg

Emergency Contraceptive

One Tablet Equals One Dose.

What You Need to Know

What is EContra EZ?

EContra EZ 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 EContra EZ is not.

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

When should I use EContra EZ?

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

EContra EZ 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 EContra EZ.

EContra EZ should not be used:

How does EContra EZ work?

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

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

How effective is EContra EZ?

If EContra EZ 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 EContra EZ worked?

You will know EContra EZ 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 EContra EZ?

If you experience side effects while taking EContra EZ you may report them to the Afaxys Health and Safety team at 1-855-888-2467 or to FDA at 1-800-FDA 1088.

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, corn starch, lactose monohydrate, magnesium stearate, povidone K-25.

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.

Afaxys logo

Manufactured for:

Afaxys Pharma LLC.

Charleston, SC, 29403, USA.

Manufactured by:

Mylan Laboratories Limited

200010574-004

REVISED: FEBRUARY 2017

Recyclable Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50102-111-01

EMERGENCY CONTRACEPTION

EContra®EZ

(Levonorgestrel) Tablet, 1.5 mg

One Tablets Equals One Dose.

Reduces chance of pregnancy after unprotected sex.

The sooner you take it, the more effective it will be

Take as soon as possible within 72 hours (3 days)

after unprotected sex

Will not harm an existing pregnancy

Not for regular birth control.

THIS PACKAGE IS NOT CHILD-RESISTANT

1 Tablet Levonorgestrel 1.5 mg

Carton
ECONTRA EZ 
levonorgestrel tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50102-111
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)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K25 (UNII: K0KQV10C35)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 251
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50102-111-12 12 in 1 PACKAGE 01/01/2015
1 NDC:50102-111-01 1 in 1 CARTON
1 NDC:50102-111-00 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 ANDA202739 01/01/2015
Labeler - Afaxys Pharma, LLC (080508656)
Registrant - Mylan Laboratories Limited (650547156)
Establishment
Name Address ID/FEI Business Operations
Mylan Laboratories Limited 677604150 analysis(50102-111) , manufacture(50102-111) , pack(50102-111) , label(50102-111)

Revised: 10/2017
Document Id: 5e7ced25-334b-4ac8-a3d2-b1b7113ce15b
Set id: 5752210e-459b-467c-8fda-b5976c07d88e
Version: 8
Effective Time: 20171027
 
Afaxys Pharma, LLC