Levonorgestrel LEVONORGESTREL XIROMED LLC 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
ANDA205329
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Levonorgestrel 1.5 mg
Inactive Ingredients
Inactive ingredients croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose poloxamer 188
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

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0370700164068
UNII
5W7SIA7YZW
Packaging

Priciple Display Panel - Blister; Principle Display Panel - Carton Levonorgestrel Tablet (levonorgestrel) tablet 1.5 mg Emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. Xiromed LLC.

Package Descriptions
  • Priciple Display Panel - Blister
  • Principle Display Panel - Carton Levonorgestrel Tablet (levonorgestrel) tablet 1.5 mg Emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. Xiromed LLC.

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 1.5 mg? The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet 1.5 mg within 72 hours (3 days) after you have had unprotected sex. Levonorgestrel tablet 1.5 mg 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 diseases (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 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

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

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 20–25°C (68–77°F) Active ingredient: levonorgestrel 1.5 mg Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188 1-844-947-6633 www.xiromed.com 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. XIROMED, LLC. Levonorgestrel tablet 1.5 mg Manufactured by: Laboratorios León Farma S.A. C/La Vallina s/n Poligono Industrial de Navatejera 24008 Villaquilambre, León, Spain Manufactured for: Xiromed, LLC. Florham Park, NJ 07932 164-06-01 Rev. 09/2023

Questions

Questions? Call 1-844-947-6633 Monday-Friday 9AM-5PM EST


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