warnings
WARNING "The FDA has not determined that the product is safe, effective and not misbranded for is intecded use"
FDA label 1d858c8b-9798-209b-e054-00144ff8d46c
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
- 1d858c8b-9797-209b-e054-00144ff8d46c
- SPL ID
- 1d858c8b-9798-209b-e054-00144ff8d46c
- Version
- 2
- Effective date
- 2015-08-17
- Source export date
- 2026-11-06
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:20:33
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 | 1d858c8b-9798-209b-e054-00144ff8d46c | id | |
| spl set id | 1d858c8b-9797-209b-e054-00144ff8d46c | 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 advice 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.