Label: LEVONORGESTREL tablet

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

Drug Label Information

Updated October 17, 2022

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  • SPL UNCLASSIFIED SECTION

    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 at 1-800-222-1222.

  • 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 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 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 1-888-885-3054 Monday - Friday 9 AM - 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Curae Pharma360 Inc.
    San Francisco, CA 94105
    NDC 73358-911-01
    Product made in Germany
    Rev. September 2022

  • PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

    NDC 73358-911-01

    Levonorgestrel Tablet
    1.5 mg

    Emergency Contraceptive

    Curae™
    Pharma360

    Reduce 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

    ONE TABLET.
    ONE STEP.

    Contains 1 levonorgestrel tablet

    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:73358-911
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW) Levonorgestrel1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Fd&C Yellow No. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGE (Light peach) Scoreno score
    ShapeROUND (Round convex) Size8mm
    FlavorImprint Code 17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73358-911-011 in 1 CARTON10/17/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20238010/17/2022
    Labeler - Curae Pharma360 Inc. (080719852)
    Registrant - Naari Pte. Limited (659345996)
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