ECONTRA ONE-STEP - levonorgestrel tablet 
Afaxys Pharma, LLC

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EContra One-StepTM
(Levonorgestrel)  Tablet 1.5 mg

Drug Facts

Active ingredient (in each tablet)

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 (1-800-222-1222)  right away.

Directions

Other information


Inactive ingredients


colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch and talc.

Questions?

Call 1-855-888-2467

Manufactured for:
Afaxys Pharma, LLC
Charleston, SC, 29403, USA 
Made in India

Code: TS/DRUGS/22/2009

Patient Information

EContra One-StepTM  
(Levonorgestrel) Tablet, 1.5 mg

Emergency Contraceptive
One Tablet. One Step.
What You Need to Know

What is EContra One-StepTM
?

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

When should I use  EContra One-StepTM?

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

EContra One-StepTM is a backup or emergency method of birth control you can use when: 


When not to use EContra One-StepTM.
 EContra One-StepTM 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 EContra One-StepTM 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 EContra One-StepTM work?

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

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

How effective is EContra One-StepTM?

If EContra One-StepTM 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 One-StepTM worked?

You will know EContra One-StepTM 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 One-StepTM?

If you have questions or need more information, call our toll-free number Afaxys Pharma, LLC at 1-855-888-2467.

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, potato starch, 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 for
Afaxys Pharma, LLC
Charleston, SC, 29403, USA.

Made in India

Code: TS/DRUGS/22/2009

Revised: 12/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg (6 Blister Carton Label)

NDC 50102-211-16

EMERGENCY CONTRACEPTIVE
EContra One-StepTM
(Levonorgestrel) Tablet, 1.5 mg
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.

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.

1 Tablet 1.5 mg

One Tablet.
One Step.

6 Mono Cartons of 1 Tablet Each

afaxys®

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg (6 Blister Carton Label)







ECONTRA ONE-STEP 
levonorgestrel tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50102-211
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 (White to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code S;11
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50102-211-16 6 in 1 PACKAGE 02/08/2018
1 NDC:50102-211-11 1 in 1 CARTON
1 NDC:50102-211-01 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 ANDA206867 02/08/2018
Labeler - Afaxys Pharma, LLC (080508656)
Registrant - Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 650381903 ANALYSIS(50102-211) , MANUFACTURE(50102-211)

Revised: 12/2018
Document Id: 8331ae06-13fc-48ec-a1a0-2c41047b6b2d
Set id: 94b23c49-dfba-4a70-ada5-e5c212e703c5
Version: 5
Effective Time: 20181229
 
Afaxys Pharma, LLC