My Choice TM LEVONORGESTREL PROFICIENT RX LP FDA Approved Use for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)
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Substance Levonorgestrel
Route
ORAL
Applications
ANDA202635
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Levonorgestrel USP 1.5 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide corn starch hypromellose lactose monohydrate magnesium stearate talc
Strengths
1.5 mg
Quantities
1 tablet
Treats Conditions
Use For Women To Reduce Chance Of Pregnancy Af Ter Unprotected Sex If A Contraceptive Failed Or If You Did Not Use Bir Th Control
Pill Appearance
Shape: round Color: white Imprint: 718

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0371205120016
UNII
5W7SIA7YZW
Packaging

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton † Compare To the active ingredient of Plan B One-Step ® NDC 71205-120-01 See New Warning My Choice ™ Levonorgestrel Tablet 1.5 mg Emergency Contraceptive • Reduces the chance of pregnancy after unprotected sex • Not for regular birth control • The sooner you take it, the more effective it will be • Take as soon as possible within 72 hours (3 days) after unprotected sex • Will not harm an existing pregnancy 1 Tablet Levonorgestrel 1.5 mg One Tablet. One Step. 71205-120-01

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton † Compare To the active ingredient of Plan B One-Step ® NDC 71205-120-01 See New Warning My Choice ™ Levonorgestrel Tablet 1.5 mg Emergency Contraceptive • Reduces the chance of pregnancy after unprotected sex • Not for regular birth control • The sooner you take it, the more effective it will be • Take as soon as possible within 72 hours (3 days) after unprotected sex • Will not harm an existing pregnancy 1 Tablet Levonorgestrel 1.5 mg One Tablet. One Step. 71205-120-01

Overview

Use for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)

Indications & Usage

Use for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)

Dosage & Administration

Directions • take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better it will work. • if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

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. Do not use • if you are already pregnant (because it will not work) • for regular bir th 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 this product you may have • menstrual changes • tiredness • dizziness • nausea • headache • breast pain • lower stomach (abdominal) pain • vomiting Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Purpose

Purpose Emergency contraceptive

Do Not Use

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

When Using

When using this product you may have • menstrual changes • tiredness • dizziness • nausea • headache • breast pain • lower stomach (abdominal) 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 (1-800-222-1222).

Storage & Handling

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 fer tilization of a released egg (joining of sperm and egg) or at tachment of a fer tilized 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 20° to 25°C (68° to 77°F)

Questions

Questions or comments? For more information, call toll free 1-800-818-4555 weekdays


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