Label: ECON MORNING AFTER- levonorgestrel tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 4, 2019

If you are a consumer or patient please visit this version.

  • 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


    • if you are already pregnant (because it will not work)
    • for regular birth control 
  • 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


    • menstrual changes                           
    • nausea
    • lower stomach (abdominal) pain
    • tiredness
    • headache
    • dizziness
    • breast pain
    • vomiting 
  • 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

    • take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
    • if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose.
  • Other information


    • read the instructions, warnings and enclosed product leaflet before use
    • this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
    • do not use if carton is open or tear strip is removed or the blister seal is broken or missing
    • store at 20° to 25°C (68° to 77°F)
  • 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
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India

    Code: TS/DRUGS/22/2009

    Revised: 10/2019

  • 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:

    • your regular birth control was used incorrectly or failed
    • you did not use any birth control method

    When not to use E-ConTM MORNING AFTER.

    E-ConTM MORNING AFTER should not be used:

    • as a regular birth control method, because it’s not as effective as regular birth control.
    • if you are already pregnant, because it will not work.
    • if you are allergic to levonorgestrel or any other ingredients in E-ConTM MORNING AFTER.

    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?

    • some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.
    • if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
    • when used as directed, E-ConTM MORNING AFTER is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
    • if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

    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
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 038, India

    Revised: 10/2019

  • 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.

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

  • INGREDIENTS AND APPEARANCE
    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
    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)