warnings
WARNING "The FDA has not determined that the product is safe, effective and not misbranded for its intended use"
FDA label f65aab22-9b34-a09d-e053-2995a90a6456
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
- 1b151ea0-5b6c-1bd1-e054-00144ff88e88
- SPL ID
- f65aab22-9b34-a09d-e053-2995a90a6456
- Version
- 2
- Effective date
- 2023-03-07
- Source export date
- 2026-08-01
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:22:37
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 | f65aab22-9b34-a09d-e053-2995a90a6456 | id | |
| spl set id | 1b151ea0-5b6c-1bd1-e054-00144ff88e88 | 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. Keep this and all medication out of reach of children. 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.
warnings and cautions
CAUTION: Federal law prohibits dispensing without prescription.