MY CHOICE TM - levonorgestrel tablet 
SUN PHARMACEUTICAL INDUSTRIES, INC.

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My Choice™

Drug Facts

Active ingredient

Levonorgestrel, USP 1.5 mg

Purpose

Emergency contraceptive

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)

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).

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

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)

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc

Questions or comments?

For more information, call toll free 1-800-818-4555 weekdays

 
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

NDC 62756-720-60

Compare To
the active ingredient of
Plan B One-Step®

See New Warning

My
Choice™
Levonorgestrel Tablet 1.5 mg
Emergency Contraceptive

1 Tablet Levonorgestrel 1.5 mg

One Tablet. One Step.

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
MY CHOICE TM 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-720
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (circular) Size8mm
FlavorImprint Code 718
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-720-601 in 1 CARTON04/01/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20263504/01/2018
Labeler - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238ANALYSIS(62756-720) , MANUFACTURE(62756-720)

Revised: 4/2022
Document Id: 8f45ff33-3872-495f-a05d-e74e0b4dc0c4
Set id: 66753300-fb61-4f09-af74-ee498b0bd595
Version: 5
Effective Time: 20220421
 
SUN PHARMACEUTICAL INDUSTRIES, INC.