Label: MORNING AFTER PILL- levonorgestrel tablet

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

Drug Label Information

Updated September 26, 2023

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  • 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 DOCTOR

    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

    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 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 of 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 blister seal is broken or missing
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

  • Questions or comments?

    Call 1-877-862-7455
    Monday - Friday 8 AM - 5 PM CST or visit us at cadenceotc.com

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Cadence OTC

    Oakland CA, 94612

    NDC 73436-2859-1


    Product made in Germany
    Issued: September 2023

  • PRINCIPAL DISPLAY PANEL

    1. NDC 73436-2859-1

    Morning After Pill TM

    Levonorgestrel 1.5 mg

    Emergency contraceptive

    Reduces chance of pregnancy after unprotected sex

    Not for regular birth control

    Won't interefere with your ability to get pregnant later

    • 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 1.5MG

    image description

  • INGREDIENTS AND APPEARANCE
    MORNING AFTER PILL 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73436-2859
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colororange (Light peach) Scoreno score
    ShapeROUND (convex) Size8mm
    FlavorImprint Code 17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73436-2859-11 in 1 CARTON10/01/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20238010/01/2023
    Labeler - Cadence Health Inc (116830263)
    Registrant - Naari Pte. Limited (659345996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haupt Pharma Muenster GmbH344172564analysis(73436-2859) , manufacture(73436-2859) , pack(73436-2859)
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