Label: LEVONORGESTREL tablet

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

Drug Label Information

Updated October 26, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Levonorgestrel 1.5mg

  • 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

    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 of taking the medication, call a healthcare professional to find out if you should repeat that 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 the carton is open or blister seal is broken or missing
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

  • Questions or comments?

    Call 1-800-224-4606.

  • PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

    NDC 49615-017-01

    Levonorgestrel Tablet

    1.5 mg

    Emergency Contraceptive

    Reduces chance of pregnancy after unprotected sex.
    Not for regular birth control.

    ONE TABLET. ONE DOSE.

    OC
    Pharma

    Contains 1 Levonorgestrel Tablet 1.5 mg

    • 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.
    PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LEVONORGESTREL 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49615-017
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW) Levonorgestrel1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Starch, corn (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49615-017-011 in 1 CARTON12/31/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20238012/01/2018
    Labeler - OC Pharma, LLC (171268936)
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