warnings
Warnings A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.
Guaifenesin
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
- Generic name
- GUAIFENESIN
- Manufacturer
- Health Pharma USA LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 31755594-3e1c-b290-e063-6394a90aba61
- SPL ID
- 45395c54-4eb3-fd26-e063-6294a90a9f93
- Version
- 5
- Effective date
- 2025-12-05
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:50
| 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 number | M012 | openfda.application_number | |
| brand name | Guaifenesin | openfda.brand_name | |
| generic name | GUAIFENESIN | openfda.generic_name | |
| manufacturer name | Health Pharma USA LLC | openfda.manufacturer_name | |
| ndc | package | 71679-309-00 | openfda.package_ndc |
| ndc | package | 71679-309-02 | openfda.package_ndc |
| ndc | product | 71679-309 | openfda.product_ndc |
| ndc11 | package | 71679030900 | derived:openfda.package_ndc |
| ndc11 | package | 71679030902 | derived:openfda.package_ndc |
| rxcui | 359601 | openfda.rxcui | |
| spl id | 45395c54-4eb3-fd26-e063-6294a90a9f93 | id | |
| spl set id | 31755594-3e1c-b290-e063-6394a90aba61 | 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.