FDA label b39efad6-13ec-4e80-84d2-1947e2e754e3

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: 7e710f03-c75d-4835-9348-cdd0d4d7317a
SPL ID: b39efad6-13ec-4e80-84d2-1947e2e754e3
Version: 1
Effective date: 2010-11-02
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:30:07

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b39efad6-13ec-4e80-84d2-1947e2e754e3	id
spl set id		7e710f03-c75d-4835-9348-cdd0d4d7317a	set_id

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Use with caution in the presence of cardiac disorders, diabetes or peripheral vascular disease. Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

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 May include drowsiness, dizziness, nervousness, insomnia, headache, palpitation, dysuria. Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.