Label: ECONTRA EZ - levonorgestrel tablet
- NDC Code(s): 50102-111-00, 50102-111-01, 50102-111-12
- Packager: Afaxys Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 7, 2018
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
One Tablet. One Dose.
What You Need to KnowClose
- What is EContra® EZ?
EContra® EZ 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.Close
- What EContra® EZ is not.
EContra® EZ will not work if you are already pregnant and will not affect an existing pregnancy. EContra® EZ will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).Close
- When should I use EContra® EZ?
- your regular birth control was used incorrectly or failed
- you did not use any birth control method
- When not to use EContra® EZ.
- 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® EZ.
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® EZ and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.Close
- How does EContra® EZ work?
EContra® EZ is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. EContra® EZ 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® EZ 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).Close
- How can I get the best results from EContra® EZ?
- How effective is EContra® EZ?
- How will I know EContra® EZ worked?
You will know EContra® EZ 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.Close
- 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® EZ 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® EZ?
- Other Information
- Keep out of reach of children:
- Do not use if the blister seal is opened.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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.
Mylan Laboratories Limited
REVISED: JANUARY 2018
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
(Levonorgestrel) Tablet, 1.5 mg
One Tablets Equals One Dose.
Reduces chance of pregnancy after unprotected sex.
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
Not for regular birth control.
THIS PACKAGE IS NOT CHILD-RESISTANT
1 Tablet Levonorgestrel 1.5 mg
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50102-111 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) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K25 (UNII: K0KQV10C35) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code 251 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50102-111-12 12 in 1 PACKAGE 01/01/2015 1 NDC:50102-111-01 1 in 1 CARTON 1 NDC:50102-111-00 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 ANDA202739 01/01/2015 Labeler - Afaxys Pharma, LLC (080508656) Registrant - Mylan Laboratories Limited (650547156) Establishment Name Address ID/FEI Business Operations Mylan Laboratories Limited 677604150 analysis(50102-111) , manufacture(50102-111) , pack(50102-111) , label(50102-111)