ECON MORNING AFTER - levonorgestrel tablet 
Aurohealth LLC

----------

E-ConTM MORNING AFTER
(levonorgestrel tablet 1.5 mg)

Drug Facts

Active ingredient (in each tablet)

Levonorgestrel USP 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 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

Patient Information

E-ConTM MORNING AFTER
(levonorgestrel tablet 1.5 mg)
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know

What is E-ConTM MORNING AFTER?

E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER is not.

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

When should I use E-ConTM MORNING AFTER?

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

E-ConTM MORNING AFTER is a backup or emergency method of birth control you can use when:


When not to use E-ConTM MORNING AFTER.

E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER work?

E-ConTM MORNING AFTER is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER?

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

How effective is E-ConTM MORNING AFTER?

If E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER worked?

You will know E-ConTM MORNING AFTER 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 E-ConTM MORNING AFTER?

If you have questions or need more information, call our toll-free number AUROHEALTH LLC at 1-855-274-4122.

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.

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 09/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -1.5 mg (1 Tablet Carton Label)

Compare to the active ingredient
of Plan B One-Step®
NDC 58602-841-57
E-Con
MORNING AFTER
levonorgestrel tablet 1.5 mg
Emergency Contraceptive
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.

1 Tablet Levonorgestrel 1.5 mg

One Tablet.
One Step.

figure 1

ECON MORNING AFTER 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-841
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)  
STARCH, POTATO (UNII: 8I089SAH3T)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (White to off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code S;11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-841-571 in 1 CARTON12/08/2015
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-841-483 in 1 PACKAGE04/28/2021
21 in 1 CARTON
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:58602-841-586 in 1 PACKAGE04/28/2021
31 in 1 CARTON
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20686712/08/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-841) , MANUFACTURE(58602-841)

Revised: 9/2021
Document Id: 469e25fc-10cd-4ca3-9576-8fd6ae335187
Set id: 177daa65-2e7d-4ff4-887e-b927d6ed8825
Version: 3
Effective Time: 20210915
 
Aurohealth LLC