OPCICON ONE-STEP - levonorgestrel tablet 
Sun Pharmaceutical Industries, Inc.

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Opcicon™ One-Step

Active ingredient

Levonorgestrel, USP 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 bir th 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 ingredient

colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc

Questions or comments?

For more information, call toll free 1-800-818-4555 weekdays

Opcicon™ One-Step

(levonorgestrel) Tablet, 1.5 mg

Emergency Contraceptive

One Tablet. One Step.

What You Need to Know

What is Opcicon™ One-Step?

Opcicon™ One-Step 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 Opcicon™ One-Step is not.

Opcicon™ One-Step will not work if you are already pregnant and will not affect an existing pregnancy. Opcicon™ One-Stepwill not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).


When should I use Opcicon™ One-Step?

The sooner you take emergency contraception, the better it works. You should use Opcicon™ One-Step within 72 hours (3 days) after you have had unprotected sex.


Opcicon™ One-Step is a backup or emergency method of birth control you can use when:


When not to use Opcicon™ One-Step.

Opcicon™ One-Step 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 Opcicon™ One-Step 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 Opcicon™ One-Step work?

Opcicon™ One-Step is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Opcicon™ One-Step 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 Opcicon™ One-Step 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 Opcicon™ One-Step?

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


How effective is Opcicon™ One-Step?

If Opcicon™ One-Step 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 Opcicon™ One-Step worked?

You will know Opcicon™ One-Step 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 Opcicon™ One-Step?

If you have questions or need more information, call our toll-free number, 1-800-818-4555.


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, hypromellose, magnesium stearate, talc, corn starch, lactose monohydrate


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:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512


Manufactured by:

Sun Pharmaceutical Industries Limited

Halol-Baroda Highway,

Halol-389 350, Gujarat, India.


ISS. 09/2017

PJPI0313B


PRINCIPAL DISPLAY PANEL

See New Warning
NDC 62756-718-60
OpciconTM One-Step
(Levonorgestrel) Tablet
1.5 mg
Emergency Contraceptive
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.
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
One Tablet.
One Step.
1 Tablet Levonorgestrel 1.5 mg


opcicon
OPCICON ONE-STEP 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-718
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (circular) Size8mm
FlavorImprint Code 718
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-718-601 in 1 CARTON09/12/2014
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20263509/12/2014
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238ANALYSIS(62756-718) , MANUFACTURE(62756-718)

Revised: 10/2018
Document Id: 95027f6e-f0a2-4154-9ede-01eafb799ea3
Set id: b67ca313-561e-471f-baf3-257b7e253c75
Version: 7
Effective Time: 20181026
 
Sun Pharmaceutical Industries, Inc.