EMPOWERED CHOICE- levonorgestrel 1.5 mg tablet

Empowered Choice by

Drug Labeling and Warnings

Empowered Choice by is a Otc medication manufactured, distributed, or labeled by Versea Diagnostics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

• 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
  

INGREDIENTS AND APPEARANCE

EMPOWERED CHOICE 
levonorgestrel 1.5 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83567-7003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)	LEVONORGESTREL	1.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white to off-white)	Score	no score
Shape	ROUND (circular)	Size	8mm
Flavor		Imprint Code	718
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83567-7003-5	1 in 1 CARTON	09/01/2023
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202635	08/25/2023

Labeler - Versea Diagnostics (118736277)