EMPOWERED CHOICE- levonorgestrel 1.5 mg tablet 
Versea Diagnostics

----------

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 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 this product you may have

• menstrual changes
• tiredness

• breast pain
• nausea
• headache

• vomiting

• lower stomach (abdominal) pain

• dizziness

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 fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized 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?

Call 1-800-397-0670

SPL UNCLASSIFIED SECTION

Distributed by:

Versea Diagnostics, LLC

Tampa, FL 33602

PRINCIPAL DISPLAY PANEL

NDC 83567-7003-5

*Compare to the active ingredient of Plan B One-Step ®

EMPOWERED CHOICE TM

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

1 Tablet Levonorgestrel 1.5 mg

One Tablet. One Step.

EMPOWERED CHOICE 
levonorgestrel 1.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83567-7003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
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:83567-7003-51 in 1 CARTON09/01/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20263508/25/2023
Labeler - Versea Diagnostics (118736277)

Revised: 7/2023
Document Id: 0167c34f-4a92-d0f9-e063-6294a90a96d3
Set id: 0167c34f-4a91-d0f9-e063-6294a90a96d3
Version: 1
Effective Time: 20230726
 
Versea Diagnostics