FDA label 244633df-2bcc-34ed-e054-00144ff8d46c

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
3c1bb39e-4b4f-4c51-8908-12d5880bde57
SPL ID
244633df-2bcc-34ed-e054-00144ff8d46c
Version
3
Effective date
2015-11-11
Source export date
2026-08-08
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/f9914d64bdcd01a4629905fd6421fbe60196ad98c430d1a297f4114fa869f148/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:18:56

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

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). Codeine: Nausea, vomiting, constipation, drowsiness, and miosis have been reported. Higher doses may induce euphoria, light headedness, dizziness, drowsiness, and depression of respiration. Pruritus and skin rashes have been rare.