Home FDA labels 78e08aad-8350-4a74-afd1-8a3a7cf1bb31 FDA label 78e08aad-8350-4a74-afd1-8a3a7cf1bb31 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 eb8c1837-d5e5-4ba2-a4b5-8c4f4be029cd
SPL ID 78e08aad-8350-4a74-afd1-8a3a7cf1bb31
Version 3
Effective date 2017-12-05
Source export date 2026-10-12
Source partition 10
Source file https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:34:23 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.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings Warnings Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel. Note: Contains FD&C Yellow No. 6 as a color additive. Sexually transmitted diseases (STDs) alert: This product does not protect agains 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 headache nausea dizziness lower stomach (abdominal) pain breast pain tiredness vomiting Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.
warnings table <table> <col/> <col/> <col/> <col/> <tbody> <tr> <td align="right" styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td styleCode=" Botrule Toprule Lrule Rrule ">menstrual changes</td> <td styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td colspan="2" styleCode=" Botrule Toprule Lrule Rrule ">headache</td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td styleCode=" Botrule Toprule Lrule Rrule ">nausea</td> <td styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td colspan="2" styleCode=" Botrule Toprule Lrule Rrule ">dizziness</td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td styleCode=" Botrule Toprule Lrule Rrule ">lower stomach (abdominal) pain</td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td colspan="2" styleCode=" Botrule Toprule Lrule Rrule ">breast pain</td> </tr> <tr> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td styleCode=" Botrule Toprule Lrule Rrule ">tiredness</td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <list listType="unordered" styleCode="Disk"> <item/> </list> </td> <td colspan="2" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>vomiting </paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.