warnings
Warnings: A persistent cough may be a sign of a serious condition. If cough persists for more than one week or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation should be considered.
FDA label 597cc41c-75d8-cc31-e053-2a91aa0a3846
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
- SPL set ID
- c3a1a47a-27ce-4565-9d6a-a2d8314357a6
- SPL ID
- 597cc41c-75d8-cc31-e053-2a91aa0a3846
- Version
- 3
- Effective date
- 2017-09-18
- 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 05:51:48
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 |
|---|---|---|---|
| spl id | 597cc41c-75d8-cc31-e053-2a91aa0a3846 | id | |
| spl set id | c3a1a47a-27ce-4565-9d6a-a2d8314357a6 | 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: Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness, headache, and rash (including urticaria) have been reported rarely.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.