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
Updated December 14, 2022
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- Drug Facts
- ACTIVE INGREDIENT
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
• lower stomach (abdominal) pain
• breast pain
- KEEP OUT OF REACH OF CHILDREN
•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
- QUESTIONS OR COMMENTS?
- Her Style™
- What You Need to KnowWhat is Her Style™?
- What Her Style™ is not.
When should I use Her Style™?
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™.
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 Style™ and 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™?
- How effective is Her Style™?
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?
•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™?
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.
Manufactured for: Ingenus Pharmaceuticals LLC
Orlando, FL 32839-6408
Made in China.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50742-352 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg Inactive Ingredients Ingredient Name Strength 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 Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code 15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50742-352-01 1 in 1 CARTON 11/30/2022 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207976 11/30/2022 Labeler - Ingenus Pharmaceuticals, LLC (833250017) Registrant - Novast Laboratories, Ltd. (527695995) Establishment Name Address ID/FEI Business Operations Novast Laboratories, Ltd. 527695995 analysis(50742-352) , label(50742-352) , manufacture(50742-352) , pack(50742-352)