warnings
Do not use if you are on hormone drug therapy for more than 6 months without consulting your physician you have an allergy or hypersensitivity to the components of the formula Keep box as it contains important information.
FDA label 9aa388ef-c576-482c-e053-2995a90af440
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
- SPL set ID
- 8780e889-b9db-4992-846a-68994656e6b7
- SPL ID
- 9aa388ef-c576-482c-e053-2995a90af440
- Version
- 3
- Effective date
- 2019-12-26
- Source export date
- 2026-09-28
- 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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:10:59
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 9aa388ef-c576-482c-e053-2995a90af440 | id | |
| spl set id | 8780e889-b9db-4992-846a-68994656e6b7 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings table
<table border="0" width="100%"> <tbody> <tr> <td> <paragraph>Do not use if</paragraph> <list listType="unordered"> <item>you are on hormone drug therapy for more than 6 months without consulting your physician</item> </list> <paragraph/> <list listType="unordered"> <item>you have an allergy or hypersensitivity to the components of the formula </item> </list> <paragraph/> <paragraph/> <paragraph>Keep box</paragraph> as it contains important information. </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.