Levonorgestrel: Package Insert and Label Information

LEVONORGESTREL- levonorgestrel tablet
HRA Pharma America, Inc.

cartonseal
Active Ingredient Purpose
Levonorgestrel, USP 1.5mg 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 medications may reduce the effectiveness of levonorgestrel.

When using this product you may have

  • menstrual changes
  • tiredness
  • breast pain
  • nausea
  • headache
  • vomiting
  • lower stomach (abdominal) pain
  • dizziness

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° — 25° C (68° — 77° F)

Inactive ingredients

colloidal silicon dioxide, corn starch, hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, potato starch, talc, titanium dioxide

Questions? call 833-515-0782

LEVONORGESTREL TABLET 1.5mg

Emergency Contraceptive

What is Levonorgestrel tablet?

Levonorgestrel tablet 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 Levonorgestrel tablet is not.

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

When should I use Levonorgestrel tablet?

The sooner you take emergency contraception, the better it works. You should use Levonorgestrel tablet within 72 hours (3 days) after you have had unprotected sex. Levonorgestrel tablet 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 Levonorgestrel tablet?

Levonorgestrel tablet 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 Levonorgestrel tablet.

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 Levonorgestrel tablet 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 Levonorgestrel tablet work?

Levonorgestrel tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel tablet 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 Levonorgestrel tablet 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 Levonorgestrel tablet?

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

How effective is Levonorgestrel tablet?

If Levonorgestrel Tablet 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 Levonorgestrel tablet worked?

You will know Levonorgestrel tablet 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, Levonorgestrel tablet 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 Levonorgestrel tablet?

If you have questions or need more information, you can contact HRA Pharma America Inc, Health and Safety Team at 833-515-0782.

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 carton is open or blister seal is broken or missing.

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

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, corn starch, hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, potato starch, talc, titanium dioxide.

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.

833-515-0782

Manufactured for:
HRA Pharma America Inc.
Morristown, NJ 07960
Under license From:
Laboratoire HRA Pharma, 92320 Chatillon, France
MADE IN GERMANY

PRINCIPAL DISPLAY PANEL

NDC 73302-911-01
Levonorgestrel
Tablet, 1.5 mg

( Emergency Contraceptive)
One Tablet, One Step
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.
This package is not child resistant.
Contains 1 Tablet Levonorgestrel 1.5 mg
Levonorgestrel Tablet, 1.5 mg
Emergency Contraceptive
MADE IN GERMANY Rev. 12/2019
Contains 1 Tablet 1.5 mg
One Tablet One Step
HRA Pharma America Inc.
Morristown, NJ 07960
▪ 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
51743613
Code 1317
74x15x105

carton
(click image for full-size original)

NDC 73302-911-01
Levonorgestrel Tablet, 1.5 mg
Emergency Contraceptive
One Tablet. One Step.
1 Tablet Levonorgestrel, USP 1.5 mg
Manufactured for:
HRA Pharma America Inc.
Morristown, NJ 07960
Under license From:
Laboratoire HRA Pharma, 92320 Chatillon, France
MADE IN GERMANY
LOT
EXP
51743611

seal
(click image for full-size original)
LEVONORGESTREL levonorgestrel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73302-911
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 1.5 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Starch, Corn
Hydrogenated Cottonseed Oil
Hydroxypropyl Cellulose, Unspecified
Hypromellose, Unspecified
Lactose Monohydrate
Magnesium Stearate
Starch, Potato
Talc
Titanium Dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73302-911-01 1 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204044 11/01/2020
Labeler — HRA Pharma America, Inc. (081160441)
Establishment
Name Address ID/FEI Operations
Laboratoire HRA Pharma 502511996 relabel (73302-911)
Establishment
Name Address ID/FEI Operations
Haupt Pharma Muenster GmbH 344172564 manufacture (73302-911)

Revised: 11/2020 HRA Pharma America, Inc.

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