FDA label 2b750d8e-2014-6213-e054-00144ff88e88
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
- 7d64b0e4-10c3-44b6-ac95-ededde5fda71
- SPL ID
- 2b750d8e-2014-6213-e054-00144ff88e88
- Version
- 3
- Effective date
- 2016-02-10
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:51:55
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 | 2b750d8e-2014-6213-e054-00144ff88e88 | id | |
| spl set id | 7d64b0e4-10c3-44b6-ac95-ededde5fda71 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: In infants and pediatric patients use with extreme caution. Excessive use in pediatric patients or certain individuals with a history of susceptibility to belladonna alkaloids may produce systemic symptoms of homatropine poisoning (see overdosage section).
warnings
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and eczematoid dermatitis. Systemic homatropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in children), dryness of the mouth, anhidrosis, blurred vision, photophobia, loss of neuromuscular coordination (ataxic gait), a rapid and irregular pulse, fever, abdominal and bladder distention, dysarthric quality of speech, and mental aberration (hallucinosis) with recovery frequently followed by retrograde amnesia.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.