FDA label b6372ca3-dba7-48f7-9661-341e533bacad

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID: b6372ca3-dba7-48f7-9661-341e533bacad
SPL ID: b6372ca3-dba7-48f7-9661-341e533bacad
Version: 1
Effective date: 2011-03-18
Source export date: 2026-10-12
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:25:59

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b6372ca3-dba7-48f7-9661-341e533bacad	id
spl set id		b6372ca3-dba7-48f7-9661-341e533bacad	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The dust or finely powdered pancreatic enzyme concentrate is irritating to the nasal mucosa and the respiratory tract. It has been documented that inhalation of the airborne powder can precipitate an asthma attack. The literature also contains several references to asthma due to inhalation in patients sensitized to pancreatic enzyme concentrates. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricemia and hyperuricosuria, Overdosage of pancreatic enzyme concentrate may cause diarrhea or transient intestinal upset.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.