Label: LEVONORGESTREL tablet

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

Drug Label Information

Updated March 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

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

  • 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
    • do not use if carton is open or tear strip is removed or blister seal is broken or missing
    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    colloidal anhydrous silica, corn starch, lactose monohydrate, magnesium stearate, potato starch and purified talc

  • Questions?

    If you have questions or need more information, call our toll-free number, x-xxx-xxx-xxxx.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Naari Pte Limited
    36 Robinson Road, #13-06
    City House, Singapore 068877
    NDC 79929-016-01
    Rev.January 2023

  • PRINCIPAL DISPLAY PANEL 

    FOR CLINIC USE ONLY.
    NOT FOR RETAIL SALE.

    NDC 79929-016-01

    levonorgestrel 1.5 mg

    emergency contraceptive

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

    One Tablet.
    One Step.

    1 Tablet Levonorgestrel 1.5 mg

    PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-146-19

  • INGREDIENTS AND APPEARANCE
    LEVONORGESTREL 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79929-016
    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, POTATO (UNII: 8I089SAH3T)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G00
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79929-016-011 in 1 BOX, UNIT-DOSE02/16/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20766002/16/2023
    Labeler - Naari Pte Limited (659345996)
    Registrant - Naari Pte Limited (659345996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Naari Pharma Private Limited915787058manufacture(79929-016) , analysis(79929-016) , pack(79929-016)
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