Label: HER STYLE- levonorgestrel tablet

  • NDC Code(s): 50742-352-01
  • Packager: Ingenus Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 14, 2022

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Levonorgestrel 1.5mg

  • PURPOSE

    Emergency contraception

  • USE

    Use for women to reduce the 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 or any other ingredients in Her Style.

    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.

  • 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 blister seal is broken or missing.

    •Store at 20° to 25°C  (68° to 77°F).

  • INACTIVE INGREDIENT

    magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.

  • QUESTIONS OR COMMENTS?

    For more information or to speak to a healthcare professional, call: 1-877-748-1970.

    (Monday-Friday, 9am to 5pm)

  • Her Style™

    (levonorgestrel Tablet) 1.5 mg

    Emergency Contraceptive

    One Tablet. One Dose.

  • What You Need to KnowWhat is Her Style™?

    Her Style™ is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.

  • What Her Style™ is not.

    Her Style™ will not work if you are already pregnant and will not affect an existing pregnancy. Her Style™ will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

  • When should I use Her Style™?

    The sooner you take emergency contraception, the better it works. You should use Her Style™ within 72 hour s (3 days) after you have had unprotected sex.

    Her Style™ is a backup or emergency method of birth control you can use when:

    •your regular birth control was used incorrectly or failed

    •you did not use any birth control method

  • When not to use Her Style™.

    Her Style™ should not be used:

    •as a regular birth control method, because it's not as effective as regular birth control.

    •if you are already pregnant, because it will not work.

    •if you are allergic to levonorgestrel or any other ingredients in Her Style™.

  • When should I talk to a doctor or pharmacist?

    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 Her Styleand increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

  • How does Her Style™ work?

    Her Style™ is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Her Style™ contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Her Style™ may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb). 

  • How can I get the best results from Her Style™?

    You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Her Style™, the better it works.

  • How effective is Her Style™?

    If Her Style™ is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.

  • How will I know Her Style™ worked?

    You will know Her Style™ has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

  • Will I experience any side effects?

    •some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.

    •if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.

    •when used as directed, Her Style™ is safe and effective.

    Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness. 

    •if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

  • What if I still have questions about Her Style™?

    If you have questions or need more information, call our toll-free number, 1-877-748-1970.

  • Other Information

    Keep out of reach of children:

    In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

    Do not use if the blister seal is opened.

    Store at room temperature 20° to 25°C  (68° to 77°F).

    Active ingredient: levonorgestrel 1.5 mg

    Inactive ingredients: magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.

    If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about, and if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

    image-01

    Manufactured for:  Ingenus Pharmaceuticals LLC

    Orlando, FL 32839-6408

    Made in China.

    I0173

    Rev. A

    Iss. 10/2022

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    2
  • INGREDIENTS AND APPEARANCE
    HER STYLE 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50742-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50742-352-011 in 1 CARTON11/30/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20797611/30/2022
    Labeler - Ingenus Pharmaceuticals, LLC (833250017)
    Registrant - Novast Laboratories, Ltd. (527695995)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novast Laboratories, Ltd.527695995analysis(50742-352) , label(50742-352) , manufacture(50742-352) , pack(50742-352)