Home FDA labels 073ab418-5a24-4ad9-a0fd-e6f192edc243 FDA label 073ab418-5a24-4ad9-a0fd-e6f192edc243 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 (canonical bytes are SHA-256 checked before publication)
SPL set ID ec4a9389-d620-4576-9d20-6dea0a7f5cf4
SPL ID 073ab418-5a24-4ad9-a0fd-e6f192edc243
Version 7
Effective date 2011-02-04
Source export date 2026-09-28
Source partition 10
Source file https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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adverse reactions ADVERSE REACTIONS Guaifenesin is well tolerated and has a wide margin of safety. Nausea and vomiting are the side effects that occur most commonly. Other reported adverse reactions have included dizziness, headache and rash (including urticaria). Rare drowsiness or mild gastrointestinal disturbances are the only side effects associated with extromethorphan in clinical use. (see also Drug Interactions)
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.