Label: TAKE ACTION- levonorgestrel tablet

  • NDC Code(s): 51285-100-88
  • Packager: Teva Women's Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/14

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

  • Drug Facts
  • Active ingredient

    Levonorgestrel 1.5mg

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  • Purpose

    Emergency contraceptive

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  • Indications

    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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  • 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 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 tear strip is removed or blister seal is broken or missing
    • store at 20-25°C (68-77°F)
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  • Inactive ingredients

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

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  • Questions?

    Call 1-866-626-6990

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  • Take ActionTM Levonorgestrel 1.5 mg Emergency Contraceptive One Tablet. One Dose.
  • What is Take ActionTM?

    Take ActionTM 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.

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  • What Take ActionTM is not.

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

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  • When should I use Take ActionTM?

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

    Take ActionTM 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
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  • When not to use Take ActionTM?

    Take ActionTM 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 Take ActionTM.
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  • How does Take ActionTM work?

    Take ActionTM is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Take ActionTM 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 Take ActionTM 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).

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  • How can I get the best results from Take ActionTM?

    You have 72 hours (3 days) to try to prevent pregnancy after unprotected sex. The sooner you take Take ActionTM, the better it works.

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  • How effective is Take ActionTM?

    If Take ActionTM 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.

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  • How will I know if Take ActionTM worked?

    You will know Take ActionTM 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.

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  • 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, Take ActionTM 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.
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  • What if I still have questions about Take ActionTM?

    If you have questions or need more information, call our toll-free number, 1-866-626-6990.

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  • Other Information
  • Keep out of reach of children:

    In case of overdose, get medical help or contact the Poison Control Center right away at 1-800-222-1222.

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  • Do not use if the blister seal is opened.

    Store at room temperature 20-25°C (68-77°F).
    You may report side effects to FDA at 1-800-FDA-1088.

     

    Active ingredient: levonorgestrel 1.5 mg

    Inactive ingredients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate

    1-866-626-6990

    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.

    ©2013 Teva Women’s Health, Inc.          799-33-100485        Iss. 10/2013          

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  • Principal Display Panel

    Take Action OTC Carton Text

    Take Action OTC Carton Text

    NDC 51285-100-88

    Emergency Contraceptive

    take
    actionTM
    LEVONORGESTREL 1.5mg

    Reduces chances of pregnancy
    after unprotected sex.
    NOT FOR REGULAR BIRTH CONTROL

    One Tablet.
    One Dose.

    Contains
    1 Tablet 1.5mg

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  • INGREDIENTS AND APPEARANCE
    TAKE ACTION 
    levonorgestrel tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51285-100
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 1.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    STARCH, CORN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    STARCH, POTATO  
    TALC  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code G00
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51285-100-88 1 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA authorized generic NDA021998 02/17/2014
    Labeler - Teva Women's Health, Inc. (017038951)
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