LEVONORGESTREL - levonorgestrel tablet 
Rugby Laboratories

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Levonorgestrel Tablet 1.5 mg

Drug Facts

Active ingredient (in each tablet)

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 (1-800-222-1222) right away.

Directions

Other information


Inactive ingredients


colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch and talc.

Questions?

Call 1-855-274-4122

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Made in India

Code: TS/DRUGS/22/2009

Patient Information

Levonorgestrel tablet 1.5 mg
Emergency Contraceptive
One Tablet. One Step.
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 works before release of an egg from the ovary. As a result, Levonorgestrel tablet usually stops or delays the release of an egg from the ovary. Levonorgestrel tablet 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 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 our toll-free number AUROHEALTH LLC at 1-855-274-4122.

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° to 25°C (68° to 77°F).

Active ingredient:
levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, 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.

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Issued: 03/2024

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -1.5 mg (1 Tablet Carton Label)

Rugby®

NDC 0536-1433-63

Compare to the active ingredient in
Plan B One-Step®†

Levonorgestrel Tablet
1.5 mg
Emergency Contraceptive
•    Reduces chance of pregnancy
      after unprotected sex.
•    Not for regular birth control.

One Tablet. One Step.

1 Tablet Levonorgestrel 1.5 mg



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg (1 Tablet Carton Label)
LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1433
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)  
STARCH, POTATO (UNII: 8I089SAH3T)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (White to off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code S;11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1433-631 in 1 CARTON05/24/2024
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20686705/24/2024
Labeler - Rugby Laboratories (079246066)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0536-1433) , MANUFACTURE(0536-1433)

Revised: 5/2024
Document Id: 076126e4-9d76-45cd-a86b-5b35c56b620a
Set id: 076126e4-9d76-45cd-a86b-5b35c56b620a
Version: 1
Effective Time: 20240524
 
Rugby Laboratories