Label: OPCICON ONE-STEP- levonorgestrel tablet
- NDC Code(s): 62756-718-60
- Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 26, 2018
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- Active ingredient
- Do not use
- Ask a doctor or pharmacist before use if
- When using this product you may have
- Keep out of reach of children.
- 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 tear strip is removed or blister seal is broken or missing
- store at 20° to 25°C (68° to 77°F)
- Inactive ingredient
- Questions or comments?
SPL UNCLASSIFIED SECTION
(levonorgestrel) Tablet, 1.5 mg
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:
- your regular birth control was used incorrectly or failed
- you did not use any birth control method
When not to use Opcicon™ One-Step.
Opcicon™ One-Step 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 Opcicon™ One-Step.
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?
- 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, Opcicon™ One-Step 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 Opcicon™ One-Step?
If you have questions or need more information, call our toll-free number, 1-800-818-4555.
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.
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Sun Pharmaceutical Industries Limited
Halol-389 350, Gujarat, India.
PRINCIPAL DISPLAY PANEL
See New Warning
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
1 Tablet Levonorgestrel 1.5 mg
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62756-718 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (circular) Size 8mm Flavor Imprint Code 718 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-718-60 1 in 1 CARTON 09/12/2014 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202635 09/12/2014 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 725959238 ANALYSIS(62756-718) , MANUFACTURE(62756-718)