Label: FEM CHOICE MORNING AFTER- levonorgestrel tablet
- NDC Code(s): 58602-712-28
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 4, 2022
If you are a consumer or patient please visit this version.
- Drug Facts
- Do not use
- Ask a doctor or pharmacist before use if you are
- WHEN USING
- 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 the blister seal is broken or missing
- store at 20° to 25°C (68° to 77°F)
- Inactive ingredients
Fem ChoiceTM morning after
(levonorgestrel tablet 1.5 mg)
One Tablet. One Step.
What You Need to Know
What is Fem ChoiceTM morning after?
Fem ChoiceTM morning after 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 Fem ChoiceTM morning after is not.
Fem ChoiceTM morning after will not work if you are already pregnant and will not affect an existing pregnancy. Fem ChoiceTM morning after will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use Fem ChoiceTM morning after?
The sooner you take emergency contraception, the better it works. You should use Fem ChoiceTM morning after within 72 hours (3 days) after you have had unprotected sex.
Fem ChoiceTM morning after 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 Fem ChoiceTM morning after.
Fem ChoiceTM morning after 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 Fem ChoiceTM morning after.
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 Fem ChoiceTM morning after 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 Fem ChoiceTM morning after work?
Fem ChoiceTM morning after is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Fem ChoiceTM morning after 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 Fem ChoiceTM morning after 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 Fem ChoiceTM morning after?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Fem ChoiceTM morning after, the better it works.
How effective is Fem ChoiceTM morning after?
If Fem ChoiceTM morning after 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 Fem ChoiceTM morning after worked?
You will know Fem ChoiceTM morning after 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, Fem ChoiceTM morning after 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 Fem ChoiceTM morning after?
If you have questions or need more information, call our toll-free number AUROHEALTH LLC at 1-855-274-4122.
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.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 032, India
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -1.5 mg (1 Tablet Carton Label)
INGREDIENTS AND APPEARANCE
FEM CHOICE MORNING AFTER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-712 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:58602-712-28 1 in 1 CARTON 01/26/2022 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 ANDA206867 01/26/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-712) , MANUFACTURE(58602-712)