warnings
WARNING: "The FDA has not determined that this product is safe, effective and not misbranded for its intended use."
FDA label f7984dd0-4cdc-ef02-e053-6394a90a5a60
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
- f695dfe4-3103-450a-aeef-8ea420e78df2
- SPL ID
- f7984dd0-4cdc-ef02-e053-6394a90a5a60
- Version
- 8
- Effective date
- 2023-03-23
- 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 06:09:12
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 | f7984dd0-4cdc-ef02-e053-6394a90a5a60 | id | |
| spl set id | f695dfe4-3103-450a-aeef-8ea420e78df2 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warning: Use only if cap and seal are unbroken. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug, if you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.