Opcicon One-Step LEVONORGESTREL SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use bir th control)

OPCICON ONE-STEP

Generic: LEVONORGESTREL
Mfr: SUN PHARMACEUTICAL INDUSTRIES, INC. FDA OTC
FunFoxMeds box
Substance Levonorgestrel
Route
ORAL
Applications
ANDA202635
Product NDC
62756-0718-00 62756-0718-60
Package NDC
62756-718-60

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Levonorgestrel USP 1.5 mg
Inactive Ingredients
Inactive ingredient 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 After 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
NDC 62756-0718-00
All Product Codes
62756-0718-00 62756-0718-60
UPC
0362756718609
UNII
5W7SIA7YZW
SPL Set IDs
b67ca313-561e-471f-baf3-257b7e253c75
Packaging

PRINCIPAL DISPLAY PANEL See New Warning NDC 62756-718-60 Opcicon TM One-Step (Levonorgestrel) Tablet 1.5 mg Emergency Contraceptive Reduces 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 One Tablet. One Step. 1 Tablet Levonorgestrel 1.5 mg carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL See New Warning NDC 62756-718-60 Opcicon TM One-Step (Levonorgestrel) Tablet 1.5 mg Emergency Contraceptive Reduces 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 One Tablet. One Step. 1 Tablet Levonorgestrel 1.5 mg carton
Overview

Use for women to reduce chance of pregnancy after 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 after 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.
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.

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Additional Information

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