JULIE- levonorgestrel tablet 
Julie Products, Inc

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Julie™

(Levonorgestrel Tablet, 1.5 mg)

Emergency Contraceptive

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

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

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.

Directions

Other information

Inactive ingredients

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

Questions or comments?

Call 1-888-213-1399. Monday- Friday 9 AM- 6 PM EST.

Julie Products, Inc.,
New York 10013

Product made in Germany

NDC 82791-332-01

Rev. May 2023

Patient Information

Julie™

LEVONORGESTREL TABLET 1.5 MG

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.

WhatJulie™ 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:

When not to use Julie™.

Julie™ should not be used:

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?

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.

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°-25°C (68° to 77°F).

Active ingredient: levonorgestrel 1.5 mg

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

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:

Julie Products, Inc.,
New York 10013

Product made in Germany

NDC 82791-332-01

Rev. May 2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Julie™

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

Reduces chance of pregnancy after unprotected sex.

Not for regular birth control.

ONE TABLET. ONE STEP.

Contains 1 levonorgestrol tablet

julie-carton

JULIE 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82791-332
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colororange (Light peach) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82791-332-011 in 1 CARTON12/27/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20238012/27/2022
Labeler - Julie Products, Inc (118628472)
Registrant - Naari Pte. Limited (659345996)
Establishment
NameAddressID/FEIBusiness Operations
Haupt Pharma Muenster GmbH344172564analysis(82791-332) , manufacture(82791-332) , pack(82791-332)

Revised: 5/2023
Document Id: fc705e79-abca-5b32-e053-6294a90a573c
Set id: 42c1be8a-74dd-407a-b5b0-04e3a3ae61e2
Version: 2
Effective Time: 20230524
 
Julie Products, Inc