warnings
WARNINGS: No additional ingredients (e.g., flavorings) should be added to the solution. PEG-3350 & ELECTROLYTES should be used with caution in patients with severe ulcerative colitis.
FDA label 61b8d92b-b9f8-491b-96dd-8754fd827545
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
- f638bdb0-d8e9-460d-9dd9-cf0b35ccdbb2
- SPL ID
- 61b8d92b-b9f8-491b-96dd-8754fd827545
- Version
- 8
- Effective date
- 2011-01-31
- Source export date
- 2026-10-12
- 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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:37:38
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 | 61b8d92b-b9f8-491b-96dd-8754fd827545 | id | |
| spl set id | f638bdb0-d8e9-460d-9dd9-cf0b35ccdbb2 | 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: Nausea, abdominal fullness and bloating are the most frequent adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.