Label: NEXT CHOICE ONE DOSE- levonorgestrel tablet

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

Drug Label Information

Updated December 5, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    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. Note: Contains FD&C Yellow No. 6 as a color additive.

    Sexually transmitted diseases (STDs) alert: This product does not protect agains HIV/AIDS or other STDs

    Do not use

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

    When using this product you may have

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

    vomiting


    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).
    • tablet is enclosed in a blister seal.  Do not use if carton is open or the blister seal is broken or missing.
    • store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
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  • Inactive ingredients

    colloidal silicon dioxide, corn starch, FD&C Yellow #6, lactose monohydrate, magnesium stearate, povidone.

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  • Questions or comments?

    Call 1-866-992-8766 or visit our Website at www.mynextchoiceonedose.com

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  • CONSUMER INFORMATION

    Next Choice ONE DOSE®  (Levonorgestrel Tablet, 1.5 mg)
    Emergency Contraceptive
    One Tablet. One Dose.
    What You Need to Know

    Contains FD&C Yellow #6 as a color additive.

    What is Next Choice One Dose®?

    Next Choice One Dose®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 Next Choice One Dose®  is not.

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

    When should I use Next Choice One Dose® ?

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

    Next Choice One Dose®  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 Next Choice One Dose®?

    Next Choice One Dose® 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 Next Choice One Dose®. 

    How does Next Choice One Dose® work?

    Next Choice One Dose® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Next Choice One Dose® 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 Next Choice One Dose® 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 Next Choice One Dose®?

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

    How effective is Next Choice One Dose®?

    If Next Choice One Dose® 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 if Next Choice One Dose® worked?

    You will know Next Choice One Dose® 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, Next Choice One Dose® 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 Next Choice One Dose®?

    If you have questions or need more information, call our toll-free number, 1-866-992-8766, or visit Actavis's My Next Choice One Dose® Website. 

    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. 

    Tablet is enclosed in a blister seal. Do not use if carton is open or the blister seal is broken or missing. 

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 

    Active ingredient: levonorgestrel 1.5 mg 

    Inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Yellow #6, lactose monohydrate, magnesium stearate, povidone. 

    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 by:
    Watson Laboratories, Inc.
    Corona, CA 92880 USA 

    Distributed by:
    Actavis Pharma, Inc.
    Parsippany, NJ 07054 USA 

    Phone: 1-866-992-8766

    www.mynextchoiceonedose.com

    Revised: October 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC 52544-065-54
    Nex Choice
    ONE DOSE®
    (Levonorgestrel) Tablet 1.5 mg

    Next Choice
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  • INGREDIENTS AND APPEARANCE
    NEXT CHOICE ONE DOSE 
    levonorgestrel tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52544-065
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Color ORANGE (Peach) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code WATSON;287
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52544-065-54 1 in 1 CARTON 05/12/2014 03/30/2018
    1 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 ANDA200670 05/12/2014 03/30/2018
    Labeler - Actavis Pharma, Inc. (119723554)
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