Label: ECONTRA ONE-STEP - levonorgestrel tablet

  • NDC Code(s): 50102-211-01, 50102-211-11, 50102-211-16
  • Packager: Afaxys Pharma, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 18, 2018

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

  • Drug Facts

    Active ingredient (in each tablet)

    Levonorgestrel 1.5 mg

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  • Purpose


    Emergency contraceptive

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  • Use

    for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

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  • 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

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  • Do not use


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

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  • When using this product you may have


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

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  • 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.
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  • 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 seal is removed
    • store at 20° to 25°C (68° to 77°F)
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  • Inactive ingredients


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

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  • Questions?

    Call 1-855-888-2467

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

    Code: TS/DRUGS/22/2009

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  • Patient Information

    Econtra® One-Step
    (levonorgestrel tablet 1.5 mg
    )
    Emergency Contraceptive
    One Tablet. One Step.
    What You Need to Know

    What is Econtra® One-Step
    ?

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

    When should I use  Econtra® One-Step?

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

    Econtra® One-Step 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® One-Step.
     Econtra® One-Step 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® One-Step. 

    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-Step 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-Step work?
     Econtra® One-Step is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Econtra® One-Step 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-Step 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® One-Step?

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

    How effective is Econtra® One-Step?

    If Econtra® One-Step 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-Step worked?

    You will know Econtra® One-Step 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, Econtra® One-Step 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 Econtra® One-Step?

    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

    Issued: 11/2017

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  • 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)







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  • INGREDIENTS AND APPEARANCE
    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)
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