warnings
Warnings Do not give to children under 12 years of age unless directed by a doctor
FDA label b8d0902d-38fc-44a0-e053-2995a90a5c32
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
- 888c83ef-5392-662b-e053-2a95a90a9682
- SPL ID
- b8d0902d-38fc-44a0-e053-2995a90a5c32
- Version
- 2
- Effective date
- 2021-01-13
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:34:28
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 | b8d0902d-38fc-44a0-e053-2995a90a5c32 | id | |
| spl set id | 888c83ef-5392-662b-e053-2a95a90a9682 | 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><content styleCode="bold">Warnings </content> </paragraph><paragraph>Do not give to children under 12 years of age unless directed by a doctor</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.