SHEWISE- levonorgestrel tablet
SheWise by
Drug Labeling and Warnings
SheWise by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, Glenmark Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- Active ingredient
- Purpose
- Indications
- Warnings
- Do not use
- ASK DOCTOR/PHARMACIST
- When using this product you may have
- Keep out of reach of children.
- Directions
-
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 tear strip is removed or blister seal is broken or missing
- Store at room temperature, 20°C to 25°C (68°F to 77°F)
- Inactive ingredients
- Questions or comments?
- Levonorgestrel Tablet 1.5 mgEmergency ContraceptiveOne Tablet, One DoseWhat You Need to Know
- What is Levonorgestrel Tablet?
- What Levonorgestrel Tablet is not.
-
When should I use Levonorgestrel Tablet?
The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet within 72 hours (3 days) after you have had unprotected sex.
Levonorgestrel tablet 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 Levonorgestrel Tablet.
-
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 levonorgestrel tablet 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 Levonorgestrel Tablet work?
Levonorgestrel tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel tablet 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 levonorgestrel tablet 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 Levonorgestrel Tablet?
- How effective is Levonorgestrel Tablet?
-
How will I know Levonorgestrel Tablet worked?
You will know levonorgestrel tablet 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, levonorgestrel tablet 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 Levonorgestrel Tablet?
- Other Information
- Keep out of reach of children:
- Do not use if the blister seal is opened.
-
Store at room temperature, 20°C to 25°C (68°F to 77°F).
Active ingredient: levonorgestrel, USP 1.5 mg
Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, 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.
Manufactured by:
Glenmark Pharmaceuticals Limited
Colvale-Bardez, Goa 403513, India
Manufactured for:
Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
May 2022
- Principal Display Panel
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SHEWISE
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 72657-108 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 (off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code G;78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 72657-108-12 1 in 1 CARTON 07/29/2022 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC: 72657-108-11 1 in 1 CARTON 07/29/2022 2 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 ANDA207044 07/29/2022 Labeler - GLENMARK THERAPEUTICS INC., USA (969085666) Establishment Name Address ID/FEI Business Operations Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE(72657-108) , ANALYSIS(72657-108)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.