warnings
WARNINGS For topical ocular use only. Not for injection or oral use.
FDA label 00904221-c0c7-49bd-b00a-8689a2a5a386
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
- ee6e2161-789b-4ba0-b234-d4b36fe41c94
- SPL ID
- 00904221-c0c7-49bd-b00a-8689a2a5a386
- Version
- 1
- Effective date
- 2011-01-05
- Source export date
- 2026-08-01
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:30:25
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 | 00904221-c0c7-49bd-b00a-8689a2a5a386 | id | |
| spl set id | ee6e2161-789b-4ba0-b234-d4b36fe41c94 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus. Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion. Some of these events were similar to the underlying disease being studied.