LEVONORGESTREL- levonorgestrel tablet 
Novel Laboratories, Inc.

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Drug Facts

Active Ingredient

Levonorgestrel 1.5mg

Purpose

Emergency contraceptive

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

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.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and talc

Questions?

For more information or to speak to a healthcare professional, call 1-800-422-8689 or visit our website at www.mywaypill.com

Levonorgestrel Tablet

Emergency Contraceptive

What You Need to Know

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:

When not to use Levonorgestrel Tablet.

Levonorgestrel Tablet 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 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?

What if I still have questions about Levonorgestrel Tablet?

If you have questions or need more information, call 1-800-422-8689, or visit our website at www.mywaypill.com

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 (68–77°F).

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate magnesium stearate, and talc

Manufactured by:

Novel Laboratories, Inc

Somerset, NJ 08873

P16223000102 Rev. 09/2017

1-800-422-8689 www.mywaypill.com

PRINCIPAL DISPLAY PANEL

Levonorgestrel Tablet, 1.5 mg

NDC 40032-622-30

emergency contraceptive

Reduces chance of pregnancy after unprotected sex.

Not for regular birth control.

Contains 1 Tablet 1.5mg

Levonorgestrel_carton
LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:40032-622
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)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40032-622-301 in 1 CARTON; Type 0: Not a Combination Product02/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20250802/15/2013
Labeler - Novel Laboratories, Inc. (793518643)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories, Inc.793518643ANALYSIS(40032-622) , MANUFACTURE(40032-622) , PACK(40032-622)

Revised: 9/2017
Document Id: af913ba6-b143-43c5-86fc-a36fd494b29d
Set id: ac13a073-a33a-45f7-8483-eecc9190195f
Version: 3
Effective Time: 20170915
 
Novel Laboratories, Inc.