warnings
Do not use for children under 12 years of age
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
- GRANULES USA, INC.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- a62e2045-8ec2-1771-e053-2995a90a03b4
- SPL ID
- 469099a1-3de3-d107-e063-6294a90adf16
- Version
- 7
- Effective date
- 2025-12-22
- Source export date
- 2026-10-30
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/8d15bdc5962e7531569eaeb5b1b2e4919574d40a6782ab67345a27b890175a00/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 19:59:03
| 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 | 213420 | derived:openfda.application_number |
| application number | ANDA213420 | openfda.application_number | |
| brand name | Guaifenesin | openfda.brand_name | |
| generic name | GUAIFENESIN | openfda.generic_name | |
| manufacturer name | GRANULES USA, INC. | openfda.manufacturer_name | |
| ndc | package | 69848-018-16 | openfda.package_ndc |
| ndc | product | 69848-018 | openfda.product_ndc |
| ndc11 | package | 69848001816 | derived:openfda.package_ndc |
| rxcui | 310621 | openfda.rxcui | |
| spl id | 469099a1-3de3-d107-e063-6294a90adf16 | id | |
| spl set id | a62e2045-8ec2-1771-e053-2995a90a03b4 | 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.