warnings
WARNINGS DO NOT GAS STERILIZE. If blister or peelable backing is damaged or broken, sterility of the enclosed vial and ampule cannot be assured. Open under aseptic conditions only.
Miochol E
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
- Brand name
- Miochol E
- Generic name
- ACETYLCHOLINE CHLORIDE
- Manufacturer
- Bausch & Lomb Incorporated
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- e701ef07-9499-4b56-931f-f4eb3eedbe24
- SPL ID
- 19c42ee4-9f98-48da-85ea-52090070c2e2
- Version
- 9
- Effective date
- 2023-03-17
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:42
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 |
|---|---|---|---|
| application applno | NDA | 020213 | derived:openfda.application_number |
| application number | NDA020213 | openfda.application_number | |
| brand name | Miochol E | openfda.brand_name | |
| generic name | ACETYLCHOLINE CHLORIDE | openfda.generic_name | |
| manufacturer name | Bausch & Lomb Incorporated | openfda.manufacturer_name | |
| ndc | package | 24208-539-20 | openfda.package_ndc |
| ndc | product | 24208-539 | openfda.product_ndc |
| ndc11 | package | 24208053920 | derived:openfda.package_ndc |
| rxcui | 876553 | openfda.rxcui | |
| rxcui | 876551 | openfda.rxcui | |
| spl id | 19c42ee4-9f98-48da-85ea-52090070c2e2 | id | |
| spl set id | e701ef07-9499-4b56-931f-f4eb3eedbe24 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine. Adverse reactions have been reported rarely, which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties, and sweating. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.