FDA label 78d74c80-71a3-4536-80f7-eeebb3ed425b
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
- 71b7afe6-4625-4467-adb7-510769da2b17
- SPL ID
- 78d74c80-71a3-4536-80f7-eeebb3ed425b
- Version
- 7
- Effective date
- 2017-08-15
- Source export date
- 2026-09-28
- 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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:21:05
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 | 78d74c80-71a3-4536-80f7-eeebb3ed425b | id | |
| spl set id | 71b7afe6-4625-4467-adb7-510769da2b17 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of CANTIL. Diarrhea may be an early symptom of incomplete intestinal obstruction especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. CANTIL may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. With overdosage, a curare-like action may occur i.e., neuromuscular blockage leading to muscular weakness and possible paralysis. It should be noted that the use of anticholinergic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis). Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the medication.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Precise frequency data from controlled clinical studies with CANTIL are not available. Gastrointestinal System: vomiting, nausea, constipation, loss of taste, bloated feeling, dry mouth Central Nervous System: mental confusion, dizziness, weakness, drowsiness, headache, nervousness Ophthalmologic: increased ocular tension, cycloplegia, blurred vision, dilation of the pupil Dermatologic-Hypersensitivity: anaphylaxis, urticaria Cardiovascular: tachycardia, palpitations Genitourinary: urinary retention, urinary hesitancy Miscellaneous: decreased sweating, drowsiness, insomnia, impotence, suppression of lactation
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.