FDA label 3f8ed365-e606-4bea-ad68-0a04b27d4039

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: f1e9c8fa-a861-436e-83d7-cb3fa794d27f
SPL ID: 3f8ed365-e606-4bea-ad68-0a04b27d4039
Version: 2
Effective date: 2016-07-07
Source export date: 2026-11-06
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:44:48

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		3f8ed365-e606-4bea-ad68-0a04b27d4039	id
spl set id		f1e9c8fa-a861-436e-83d7-cb3fa794d27f	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 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 In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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