MY CHOICE TM (LEVONORGESTREL) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]

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MY CHOICE TM (LEVONORGESTREL) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]
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NDC 62756-720-60
Set ID 66753300-fb61-4f09-af74-ee498b0bd595
Category HUMAN OTC DRUG LABEL
Packager SUN PHARMACEUTICAL INDUSTRIES, INC.
Generic Name
Product Class
Product Number
Application Number ANDA202635
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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 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 bir th 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 fer tilization of a released egg (joining of sperm and egg) or at tachment of a fer tilized 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:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901
  • PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

    †Compare To
    the active ingredient of
    Plan B One-Step®

    NDC 62756-720-60

    See New Warning

    My
    Choice™

    Levonorgestrel Tablet 1.5 mg
    Emergency Contraceptive

    •
    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

    1 Tablet Levonorgestrel 1.5 mg

    One Tablet. One Step.

    PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MY CHOICE TM 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-720
    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
    ColorWHITE (white to off-white) Scoreno score
    ShapeROUND (circular) Size8mm
    FlavorImprint Code 718
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-720-601 in 1 CARTON04/01/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20263504/01/2018
    Labeler - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited725959238ANALYSIS(62756-720) , MANUFACTURE(62756-720)
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