Label: EMERGENCY CONTRACEPTIVE- levonorgestrel tablet

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

Drug Label Information

Updated June 2, 2023

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  • Active ingredient ( in each tablet)

    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 medication may reduce the effectiveness of levonorgestrel.

    When using the product you may have

    • menstrual changes
    • tiredness
    • breast pain
    • nausea
    • headache
    • vomiting
    • lower stomach (abdominal) pain
    • dizziness
  • Keep out of reach children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
    • this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachmentof a fertilized egg to the uterus (implantation).
    • do not use if package is open or blister seal is broken or missing
    • store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
  • Inactive ingredients

    croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    Compare to the active ingredient in Plan B One-Step**

    Levonorgestrel Tablet 1.5 mg

    Emergency Contraceptive

    Reduces chances of pregnancy after unprotected sex

    Not for regular birth control

    One Tablet. One Step

    • 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

    Tablet

    *This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One Step®.

    Distributed by:

    RUGBY LABORATORIES

    Indianapolis, IN 46268

  • Package label

    Levonorgestrel 1.5 mg

    RUGBY Emergency Contraceptive

  • INGREDIENTS AND APPEARANCE
    EMERGENCY CONTRACEPTIVE 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1391(NDC:70700-164)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    Product Characteristics
    Colorwhite (White to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1391-631 in 1 CARTON08/01/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20532908/01/2023
    Labeler - Rugby Laboratories, Inc. (079246066)
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