Label: AFTERA- levonorgestrel tablet
- NDC Code(s): 51285-103-88
- Packager: Teva Women's Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Updated October 24, 2017
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- Active ingredient
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.
When using this product you may have
- menstrual changes
- lower stomach (abdominal) pain
- breast pain
- Keep out of reach of children.
- 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
- 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 20-25°C (68-77°F)
- Inactive ingredients
- CONSUMER INFORMATION
- What is AFTERA®?
- What AFTERA is not.
When should I use AFTERA?
The sooner you take emergency contraception, the better it works. You should use AFTERA within 72 hours (3 days) after you have had unprotected sex.
AFTERA 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 AFTERA.
AFTERA 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 AFTERA.
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 AFTERA 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 AFTERA work?
AFTERA is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. AFTERA 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 AFTERA 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 AFTERA?
- How effective is AFTERA?
How will I know AFTERA worked?
You will know AFTERA 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, AFTERA 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 AFTERA?
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 20–25°C (68–77°F).
You may report side effects to FDA at 1-800-FDA-1088.
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, potato starch, 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.
©2017 Teva Women’s Health, Inc.
Rev. 9/2017 Printed in USA
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INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51285-103 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 Score no score Shape ROUND Size 8mm Flavor Imprint Code G00 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51285-103-88 1 in 1 BOX, UNIT-DOSE 10/20/2014 05/31/2020 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 NDA AUTHORIZED GENERIC NDA021998 10/20/2014 05/31/2020 Labeler - Teva Women's Health, Inc. (017038951)