Label: EMPOWERED CHOICE- levonorgestrel 1.5 mg tablet

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

Drug Label Information

Updated July 26, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Levonorgestrel, USP 1.5 mg

  • PURPOSE

    Emergency Contraceptive

  • USE

    for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (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 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 carton is open or tear strip is removed or blister seal is broken or missing
    store at 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENTS

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

  • QUESTIONS?

    Call 1-800-397-0670

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Versea Diagnostics, LLC

    Tampa, FL 33602

  • PRINCIPAL DISPLAY PANEL

    NDC 83567-7003-5

    *Compare to the active ingredient of Plan B One-Step ®

    EMPOWERED CHOICE TM

    Levonorgestrel Tablet 1.5 mg

    Emergency Contraceptive

    1 Tablet Levonorgestrel 1.5 mg

    One Tablet. One Step.

    • Reduces the 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
      Empowered Choice

  • INGREDIENTS AND APPEARANCE
    EMPOWERED CHOICE 
    levonorgestrel 1.5 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83567-7003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUND (circular) Size8mm
    FlavorImprint Code 718
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83567-7003-51 in 1 CARTON09/01/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20263508/25/2023
    Labeler - Versea Diagnostics (118736277)