FDA label 03d21323-77ac-18ef-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
- e5fd8476-418a-4149-a688-205ea943b30c
- SPL ID
- 03d21323-77ac-18ef-e054-00144ff8d46c
- Version
- 4
- Effective date
- 2024-07-25
- 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 05:45:54
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 | 03d21323-77ac-18ef-e054-00144ff8d46c | id | |
| spl set id | e5fd8476-418a-4149-a688-205ea943b30c | 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 can occur with drug use (fever and heat stroke due to decreased sweating). 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. Like other anticholinergic agents, ANASPAZ may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Anticholinergic 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 12 to 48 hours after drug discontinuation. Elderly patients may react with excitement, agitation, drowsiness, and other unfavorable manifestations to even small doses of ANASPAZ.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Not all the following adverse reactions have been associated with ANASPAZ, but have been reported for drugs in the same pharmacological class, with anticholinergic / antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy, urinary retention, tachycardia, palpitations, blurred vision, mydriasis, cycloplegia, increased intraocular pressure, dry eyes, headache, nervousness, drowsiness, dizziness, weakness, mental confusion and/or excitement (especially in geriatric patients), flushing, insomnia, fever, altered sense of taste, nausea, vomiting, dysphagia, heartburn, constipation, bloated feeling, suppression of lactation, impotence, and decreased sweating. Allergic reactions or drug idiosyncrasies such as anaphylaxis, urticaria and other dermal manifestations may also occur.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.