Label: LEVONORGESTREL tablet

  • NDC Code(s): 76519-1164-0
  • Packager: H.J. Harkins Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 18, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Levonorgestrel USP 1.5 mg

  • PURPOSE

    Emergency contraceptive

  • INDICATIONS & USAGE

    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
    nausea
    lower stomach (abdominal) pain
    tiredness
    headache
    dizziness
    breast pain
    vomiting

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    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 blister seal is broken or missing .
    store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].

  • INACTIVE INGREDIENT

    colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    LEVONORGESTREL 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76519-1164
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code LU;S25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76519-1164-01 in 1 BOX; Type 0: Not a Combination Product11/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20144611/15/2017
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894manufacture(76519-1164) , relabel(76519-1164) , repack(76519-1164)