Label: BIONAFEM- levonorgestrel tablet

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

Drug Label Information

Updated April 12, 2019

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

  • Drug Facts

  • Active ingredient

    Levonorgestrel, USP 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
  • 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.

    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, potato starch, talc

  • Questions or comments?

    For more information, call toll free 1-888-235-2466 weekdays

  • SPL UNCLASSIFIED SECTION

    Plan B One-Step® is a registered trademark of Women's Capital Corporation

    Distributed by:

    BIONPHARMA

    600 Alexander Road,

    Princeton, NJ 08540

    Manufactured by:

    Glenmark Pharmaceuticals Ltd.

    Colvale-Bardez, Goa 403513, India

    MADE IN INDIA

    GO/DRUGS/785

    01/19

  • Package Label.Principal Display Panel

    NDC 69452-243-60

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

    BionaFemTM

    Levonorgestrel Tablet 1.5 mg

    Emergency Contraceptive

    One Tablet. One Step.

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

    Contains 1 Tablet, 1.5 mg

    Note: This package in not child resistant. Keep this and all medication out of the reach of children.

    Bionafem Carton

  • INGREDIENTS AND APPEARANCE
    BIONAFEM 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-243
    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)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G;78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-243-601 in 1 CARTON04/14/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20704404/14/2019
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Glenmark Pharmaceuticals Limited (650425929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Glenmark Pharmaceuticals Limited677318665MANUFACTURE(69452-243)