warnings
WARNINGS No additional ingredients, e.g. flavorings, should be added to the solution. Polyethylene glycol 3350 and electrolytes for oral solution should be used with caution in patients with severe ulcerative colitis.
FDA label cfb193af-22eb-4f7b-932a-fed5014ddf25
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
- 29dd5355-2141-4a66-aa06-43708b3b33c7
- SPL ID
- cfb193af-22eb-4f7b-932a-fed5014ddf25
- Version
- 2
- Effective date
- 2010-01-26
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:49:56
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 | cfb193af-22eb-4f7b-932a-fed5014ddf25 | id | |
| spl set id | 29dd5355-2141-4a66-aa06-43708b3b33c7 | 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 common adverse reactions (occurring in up to 50% of patients) to administration of polyethylene glycol 3350 and electrolytes for oral solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrate on chest X-ray after vomiting and aspirating PEG.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.