Label: LEVONORGESTREL tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 11, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Levonorgestrel, USP 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
    •
    dizziness
    •
    nausea
    •
    headache
    •
    breast pain
    •
    lower stomach (abdominal) pain
    •
    vomiting

    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 or comments?

    For more information, call toll free 1-800-818-4555 weekdays

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

    NDC 0536-1142-63

    Rugby®

    COMPARE TO
    active ingredient in
    PLAN B ONE-STEP®†

    See New Warning

    Levonorgestrel Tablet

    1.5 mg

    Emergency Contraceptive

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

    1 Tablet Levonorgestrel 1.5 mg

    ONE TABLET. ONE STEP.

    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:0536-1142
    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)  
    starch, corn (UNII: O8232NY3SJ)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    talc (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1142-631 in 1 CARTON11/01/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20263511/01/2017
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited725959238MANUFACTURE(0536-1142)
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