Label: JULIE- levonorgestrel tablet
- NDC Code(s): 82791-335-01
- Packager: Julie Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 14, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Use
- Directions
- Warnings
- Do Not Use
- Ask a Doctor or Pharmacist Before Use If You Are
- When Using
- Keep Out of Reach of Children
- Other Information
- Inactive Ingredients
- Questions?
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Information for Patients
Julie TM
LEVONORGESTREL TABLET 1.5 MG
- Emergency Contraceptive
- One Tablet. One Step.
- What You Need To Know
What is Julie™?
Julie™ 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 Julie™ is not.
Julie™ will not work if you are already pregnant and will not affect an existing pregnancy. Julie™ will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use Julie™?
The sooner you take emergency contraception, the better it works. You should use Julie™ within 72 hours (3 days) after you have had unprotected sex.
Julie™ 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 Julie™.
Julie™ 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 Julie™.
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 Julie™ 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 Julie™ work?
Julie works before release of an egg from the ovary. As a result, Julie usually stops or delays TM the release of an egg from the ovary. Julie is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy.
How can I get the best results from Julie™?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Julie™, the better it works.
How effective is Julie™?
If Julie™ 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 Julie™ worked?
You will know Julie™ 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, Julie™ 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 Julie™?
If you have questions or need more information, call our toll free number, 1-888-213-1399. Monday- Friday 9 AM- 6 PM EST.
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -1.5 mg (1 Tablet Carton Label)
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INGREDIENTS AND APPEARANCE
JULIE
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82791-335 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 STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) STARCH, POTATO (UNII: 8I089SAH3T) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code EE1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82791-335-01 1 in 1 BOX, UNIT-DOSE 02/20/2025 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 ANDA207660 02/20/2025 Labeler - Julie Products Inc (118628472) Registrant - Naari Pharma Private Limited (915787058) Establishment Name Address ID/FEI Business Operations Naari Pharma Private Limited 915787058 manufacture(82791-335)

