Label: MY WAY- levonorgestrel tablet
- NDC Code(s): 43386-622-30
- Packager: Lupin Pharmaceuticals,Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 17, 2016
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- Active Ingredient
- Do not use
- 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 blister seal is broken or missing
- store at 20-25°C (68-77°F)
- Inactive ingredients
What You Need to Know
What is My Way?
My Way 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 My Way is not.
My Way will not work if you are already pregnant and will not affect an existing pregnancy. My Way will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use My Way?
The sooner you take emergency contraception, the better it works. You should use My Way within 72 hours (3 days) after you have had unprotected sex.
My Way 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
My Way 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 My Way .
My Way is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. My Way 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 My Way 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 My Way?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take My Way, the better it works.
How effective is My Way?
If My Way 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 My Way worked?
You will know My Way 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, My Way 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.
If you have questions or need more information, call 1-800-422-8689, or visit our website at www.mywaypill.com
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).
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, 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.
Novel Laboratories, Inc.
Somerset, NJ 08873
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43386-622 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) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43386-622-30 1 in 1 CARTON; Type 0: Not a Combination Product 02/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202508 02/15/2013 Labeler - Lupin Pharmaceuticals,Inc. (089153071) Registrant - GAVIS Pharmaceuticals, LLC (829838551) Establishment Name Address ID/FEI Business Operations Novel Laboratories, Inc. 793518643 analysis(43386-622) , manufacture(43386-622)