Label: ECONTRA ONE-STEP - levonorgestrel tablet
- NDC Code(s): 50102-211-01, 50102-211-11, 50102-211-16
- Packager: Afaxys Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 29, 2018
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- Drug Facts
Active ingredient (in each tablet)Close
Levonorgestrel 1.5 mg
for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)Close
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
- if you are already pregnant (because it will not work)
- for regular birth control
- 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.Close
- When using this product you may have
- menstrual changes
- lower stomach (abdominal) pain
- breast pain
- 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.Close
- take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
- if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose.
- Other information
- 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 seal is removed
- store at 20° to 25°C (68° to 77°F)
- Inactive ingredients
colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch and talc.Close
Afaxys Pharma, LLC
Charleston, SC, 29403, USA
Made in India
- Patient Information
(Levonorgestrel) Tablet, 1.5 mg
One Tablet. One Step.
What You Need to Know
What is EContra One-StepTM?
EContra One-StepTM 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 EContra One-StepTM is not.
EContra One-StepTM will not work if you are already pregnant and will not affect an existing pregnancy. EContra One-StepTM will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use EContra One-StepTM?
The sooner you take emergency contraception, the better it works. You should use EContra One-StepTM within 72 hours (3 days) after you have had unprotected sex.
EContra One-StepTM 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 EContra One-StepTM.
EContra One-StepTM 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 EContra One-StepTM.
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 EContra One-StepTM 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 EContra One-StepTM work?
EContra One-StepTM is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. EContra One-StepTM 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 EContra One-StepTMmay 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 EContra One-StepTM?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take EContra One-StepTM, the better it works.
How effective is EContra One-StepTM?
If EContra One-StepTM 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 EContra One-StepTM worked?
You will know EContra One-StepTM 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, EContra One-StepTM 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 EContra One-StepTM?Close
If you have questions or need more information, call our toll-free number Afaxys Pharma, LLC at 1-855-888-2467.
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.
Afaxys Pharma, LLC
Charleston, SC, 29403, USA.
Made in India
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 mg (6 Blister Carton Label)
(Levonorgestrel) Tablet, 1.5 mg
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 1.5 mg
6 Mono Cartons of 1 Tablet Each
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50102-211 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) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, POTATO (UNII: 8I089SAH3T) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (White to off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code S;11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50102-211-16 6 in 1 PACKAGE 02/08/2018 1 NDC:50102-211-11 1 in 1 CARTON 1 NDC:50102-211-01 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 ANDA206867 02/08/2018 Labeler - Afaxys Pharma, LLC (080508656) Registrant - Aurobindo Pharma Limited (650082092) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(50102-211) , MANUFACTURE(50102-211)