LEVONORGESTREL - levonorgestrel tablet 
Pharmacist Pharmaceutical, LLC

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Drug Facts

Active Ingredient

Levonorgestrel 1.5mg

Purpose

Emergency contraceptive

Indications

Use for women 17 years of age and older 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

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 or comments?

For more information or to speak to a healthcare professional, call 1-800-224-4606 or visit www.ecpill.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:

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 1-800-224-4606, or visit our website at www.ecpill.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

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:

Pharmacist Pharmaceutical, LLC
Salem, VA 24153

PI6223003501

Iss: 03/2014

PRINCIPAL DISPLAY PANEL

Levonorgestrel Tablet, 1.5 mg

NDC 63704-010-01

emergency contraceptive

Reduces chance of pregnancy after unprotected sex.

Not for regular birth control.

Contains 1 Tablet 1.5mg

C:\Users\kvyas\Desktop\spl components\levo-new.jpg
LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63704-010
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:63704-010-011 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20250803/12/2014
Labeler - Pharmacist Pharmaceutical, LLC (830838251)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories, Inc.793518643MANUFACTURE(63704-010)

Revised: 4/2014
Document Id: 840a68ff-8ee6-42d1-b371-6310093ec565
Set id: 20048cf0-9fe6-43f9-8137-4021e5ff910e
Version: 1
Effective Time: 20140415
 
Pharmacist Pharmaceutical, LLC