Levonorgestrel LEVONORGESTREL GLENMARK THERAPEUTICS INC., USA FDA Approved Use For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
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Substance Levonorgestrel
Route
ORAL
Applications
ANDA207044
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Levonorgestrel USP 1.5mg
Inactive Ingredients
Inactive ingredients Colloidal silicon dioxide corn starch lactose monohydrate magnesium stearate potato starch talc
Strengths
1.5 mg
Treats Conditions
Use For Women To Reduce Chance Of Pregnancy After Unprotected Sex If A Contraceptive Failed Or If You Did Not Use Birth Control
Pill Appearance
Shape: round Color: white Imprint: G;78

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0372657123112
UNII
5W7SIA7YZW
Packaging

Principal Display Panel carton

Package Descriptions
  • Principal Display Panel carton

Overview

Use For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Indications & Usage

Use For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Dosage & Administration

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

Warnings & Precautions
Warnings Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted disease (STDs) alert: This product does not protect against HIV/AIDS or other STDs
Purpose

Purpose Emergency contraceptive

Do Not Use

Do not use • if you are already pregnant (because it will not work) • for regular birth control

When Using

When using this product you may have • menstrual changes • nausea • lower stomach (abdominal) pain • tiredness • headache • dizziness • breast pain • vomiting

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

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 February 2023

Questions

Questions or comments? Call 1 (888) 721-7115 or visit www.glenmarkpharma-us.com


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