Label: LEVONORGESTREL tablet

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

Drug Label Information

Updated June 29, 2021

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

  • Drug Facts

  • Active ingredient

    Levonorgestrel 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• tiredness  • breast pain
    • nausea• headache  • vomiting
    • lower stomach (abdominal) pain • dizziness 
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control center 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 package is open or blister seal is broken or missing
    store levonorgestrel tablets 1.5 mg at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]
  • Inactive ingredients

    cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, poloxamer 188

  • Questions?

    Call 1-844-947-6633  Monday-Friday 9AM-5PM EST

  • Levonorgestrel Tablets 1.5 mgEmergency ContraceptiveOne Tablet. One Step.What You Need to Know

  • What is levonorgestrel tablets 1.5 mg?

    Levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg is not.

    Levonorgestrel tablets 1.5 mg will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel tablets 1.5 mg will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

  • When should I use levonorgestrel tablets 1.5 mg?

    The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablets 1.5 mg within 72 hours (3 days) after you have had unprotected sex.

    Levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg.

    Levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg.
  • 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 levonorgestrel tablet 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 levonorgestrel tablets 1.5 mg work?

    Levonorgestrel tablets 1.5 mg is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg?

    You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take levonorgestrel tablets 1.5 mg, the better it works.

  • How effective is levonorgestrel tablets 1.5 mg?

    If levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg worked?

    You will know levonorgestrel tablets 1.5 mg 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, levonorgestrel tablets 1.5 mg 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 levonorgestrel tablets 1.5 mg?

    If you have questions or need more information, call our toll-free number, 1-844-947-6633, or visit our website at www.xiromed.com.

  • 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.

  • STORAGE AND HANDLING

    Store levonorgestrel tablets 1.5 mg at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

    Active ingredient: levonorgestrel 1.5 mg

    Inactive ingredients: cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, poloxamer 188

    1-844-947-6633

    www.xiromed.com

    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.

    XIROMED, LLC.
    Levonorgestrel tablets 1.5 mg

    Manufactured by:
    Laboratorios León Farma S.A.
    C/La Vallina s/n
    Poligono Industrial de
    Navatejera
    24008 Villaquilambre, León,
    Spain


    Manufactured for:
    Xiromed, LLC.
    Florham Park, NJ 07932





    Revised: December 2019



  • Priciple Display Panel - Blister

    blister.jpg

  • Principle Display Panel - Carton

    Levonorgestrel Tablets
    (levonorgestrel) tablets 1.5 mg
    Emergency contraceptive
    Reduces chance of pregnancy after unprotected sex.
    Not for regular birth control.
    Xiromed LLC.

    ctn.jpg


  • INGREDIENTS AND APPEARANCE
    LEVONORGESTREL 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70700-164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW) Levonorgestrel1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70700-164-061 in 1 CARTON03/13/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20532903/13/2020
    Labeler - Xiromed LLC (080228637)
    Registrant - Xiromed Pharma España, S.L (468835741)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios León Farma S.A.467782459manufacture(70700-164) , analysis(70700-164) , pack(70700-164)