FDA label 968bf634-dc38-39da-e053-2995a90a55fa

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
575d7afb-b735-fe99-e053-2991aa0aea71
SPL ID
968bf634-dc38-39da-e053-2995a90a55fa
Version
2
Effective date
2019-11-04
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:25

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"><item/></list></td><td styleCode=" Botrule Toprule Lrule Rrule ">menstrual changes</td><td styleCode=" Botrule Toprule Lrule Rrule "><list listType="unordered"><item/></list></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule ">headache</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "><list listType="unordered"><item/></list></td><td styleCode=" Botrule Toprule Lrule Rrule ">nausea</td><td styleCode=" Botrule Toprule Lrule Rrule "><list listType="unordered"><item/></list></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule ">dizziness</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "><list listType="unordered"><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"><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"><item/></list></td><td styleCode=" Botrule Toprule Lrule Rrule ">tiredness</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule "><list listType="unordered"><item/></list></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule "><paragraph>vomiting </paragraph></td></tr></tbody></table>