warnings
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 India Ltd
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e3531e9e-2ae7-4188-b95a-90f35613fc05
- SPL ID
- 44f3065d-0001-622b-e063-6394a90a2775
- Version
- 8
- Effective date
- 2025-12-02
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:57:17
| 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 India Ltd | openfda.manufacturer_name | |
| ndc | package | 62207-840-93 | openfda.package_ndc |
| ndc | package | 62207-840-71 | openfda.package_ndc |
| ndc | package | 62207-840-99 | openfda.package_ndc |
| ndc | package | 62207-839-72 | openfda.package_ndc |
| ndc | product | 62207-839 | openfda.product_ndc |
| ndc | product | 62207-840 | openfda.product_ndc |
| ndc11 | package | 62207083972 | derived:openfda.package_ndc |
| ndc11 | package | 62207084071 | derived:openfda.package_ndc |
| ndc11 | package | 62207084093 | derived:openfda.package_ndc |
| ndc11 | package | 62207084099 | derived:openfda.package_ndc |
| rxcui | 636522 | openfda.rxcui | |
| rxcui | 310621 | openfda.rxcui | |
| spl id | 44f3065d-0001-622b-e063-6394a90a2775 | id | |
| spl set id | e3531e9e-2ae7-4188-b95a-90f35613fc05 | set_id | |
| unii | 495W7451VQ | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Other information Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. store between 20-25°C (68-77°F)
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.