Empowered Choice

Manufacturer
Versea Diagnostics
Effective date
2023-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:57

Label at a glance#

ProductEmpowered Choice
Active ingredientLEVONORGESTREL
Label structure11 sections

Dosage and administration

• 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel, USP 1.5 mg

PURPOSE

OTC - PURPOSE SECTION

Emergency Contraceptive

USE

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

INACTIVE INGREDIENT SECTION

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

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-397-0670

SPL UNCLASSIFIED SECTION

Distributed by:

Versea Diagnostics, LLC

Tampa, FL 33602

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 Empowered ChoiceEmpowered Choice

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2663935Empowered Choice 1.5 MG Oral TabletPSN1
483325levonorgestrel 1.5 MG Oral TabletPSN1
2663935levonorgestrel 1.5 MG Oral Tablet [Empowered Choice]SBD1
483325levonorgestrel 1.5 MG Oral TabletSCD1
2663935Empowered Choice 1.5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVONORGESTREL Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83567-7003-52025-01-30C16284748780-12cef2736-b04a-d83d-e063-dadaa90ab31f0167c34f-4a91-d0f9-e063-6294a90a96d3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83567-7003-5Empowered Choice1 in 1 CARTONTABLET11
83567-7003-5Empowered Choice1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83567-7003EMPOWERED CHOICE (LEVONORGESTREL 1.5 MG) TABLET [VERSEA DIAGNOSTICS]12 package rows20230825_0167c34f-4a91-d0f9-e063-6294a90a96d3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83567-700383567-7003-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0167c34f-4a92-d0f9-e063-6294a90a96d30167c34f-4a91-d0f9-e063-6294a90a96d32023-07-26WarningsExact identifier
spl id: 0167c34f-4a92-d0f9-e063-6294a90a96d3
spl set id: 0167c34f-4a91-d0f9-e063-6294a90a96d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.