Label: ECONTRA EZ- levonorgestrel tablet

  • NDC Code(s): 50102-111-00, 50102-111-01, 50102-111-12
  • Packager: Afaxys Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2016

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

  • SPL UNCLASSIFIED SECTION

    Emergency Contraceptive

    One Tablet Equals One Dose.

    What You Need to Know

    Close
  • 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.

    Close
  • 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).

    Close
  • 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
    Close
  • When not to use EContra EZ.

    EContra EZ 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 EContra EZ.
    Close
  • 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).

    Close
  • 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.

    Close
  • 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.

    Close
  • 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.

    Close
  • 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, EContra EZ 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.
    Close
  • 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.

    Close
  • 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.

    Close
  • Do not use if the blister seal is opened.

    Store at room temperature 20° to 25°C (68° to 77°F).

    Close
  • ACTIVE INGREDIENT

    Active ingredient: levonorgestrel 1.5 mg

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone K-25.

    Close
  • SPL UNCLASSIFIED SECTION

    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, Inc.

    Charleston, SC, 29403, USA.

    Manufactured by:

    Jai Pharma Ltd., India

    200010574-003

    REVISED: AUGUST 2016

    Recyclable Logo
    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    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 Inc. (832701960)
    Registrant - Jai Pharma Limited (650882132)
    Establishment
    Name Address ID/FEI Business Operations
    Jai Pharma Limited 677604150 analysis(50102-111) , manufacture(50102-111) , pack(50102-111) , label(50102-111)
    Close