PHYSOSTIGMINE SALICYLATE

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)

Brand name
PHYSOSTIGMINE SALICYLATE
Generic name
PHYSOSTIGMINE SALICYLATE
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
9a448a78-356c-50f7-e053-2995a90adefa
SPL ID
f1deeef3-92c7-a88e-e053-2a95a90a74a3
Version
3
Effective date
2023-01-09
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:03:47
Harmonized routes table
Harmonized routes
INTRAVENOUS

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. If excessive symptoms of salivation, emesis, urination and defecation occur, the use of Physostigmine Salicylate Injection should be terminated. If excessive sweating or nausea occur, the dosage should be reduced. Intravenous administration should be at a slow, controlled rate, no more than 1 mg per minute (see DOSAGE . Rapid administration can cause bradycardia, hypersalivation leading to a respiratory difficulties and possible convulsions. An overdosage of Physostigmine Salicylate Injection can cause a cholinergic crisis.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Nausea, vomiting and salivation; can be offset by reducing dosage. Bradycardia and convulsions, if intravenous administration is too rapid. See DOSAGE AND ADMINISTRATION.

Reported adverse events (FAERS/openFDA)#

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