warnings
WARNING .
Guaifenesin Extended-Release 600 mg
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
- Guaifenesin Extended-Release 600 mg
- Generic name
- GUAIFENESIN
- Manufacturer
- Guardian Drug Company
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 20f9e083-419d-429d-a570-24b312ed5d2a
- SPL ID
- 8186c3e8-1ae5-459d-8771-ad2d1ae95387
- Version
- 2
- Effective date
- 2018-02-28
- Source export date
- 2026-10-12
- 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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:31:42
| Harmonized routes |
|---|
| ORAL |
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 | ANDA | 209215 | derived:openfda.application_number |
| application number | ANDA209215 | openfda.application_number | |
| brand name | Guaifenesin Extended-Release 600 mg | openfda.brand_name | |
| brand name | Guaifenesin Extended-Release 1200 mg | openfda.brand_name | |
| generic name | GUAIFENESIN | openfda.generic_name | |
| manufacturer name | Guardian Drug Company | openfda.manufacturer_name | |
| ndc | package | 53041-233-38 | openfda.package_ndc |
| ndc | package | 53041-233-32 | openfda.package_ndc |
| ndc | package | 53041-233-30 | openfda.package_ndc |
| ndc | package | 53041-234-47 | openfda.package_ndc |
| ndc | package | 53041-234-58 | openfda.package_ndc |
| ndc | package | 53041-234-37 | openfda.package_ndc |
| ndc | product | 53041-234 | openfda.product_ndc |
| ndc | product | 53041-233 | openfda.product_ndc |
| ndc11 | package | 53041023437 | derived:openfda.package_ndc |
| ndc11 | package | 53041023447 | derived:openfda.package_ndc |
| ndc11 | package | 53041023338 | derived:openfda.package_ndc |
| ndc11 | package | 53041023330 | derived:openfda.package_ndc |
| ndc11 | package | 53041023458 | derived:openfda.package_ndc |
| ndc11 | package | 53041023332 | derived:openfda.package_ndc |
| rxcui | 636522 | openfda.rxcui | |
| rxcui | 310621 | openfda.rxcui | |
| spl id | 8186c3e8-1ae5-459d-8771-ad2d1ae95387 | id | |
| spl set id | 20f9e083-419d-429d-a570-24b312ed5d2a | set_id | |
| unii | 495W7451VQ | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.