FDA label 449ed61a-a26b-4c38-8adc-59f8b190f43c

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
016df73a-74a0-4ad0-a040-3d18c049aca3
SPL ID
449ed61a-a26b-4c38-8adc-59f8b190f43c
Version
1
Effective date
2010-04-07
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:05:46

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: DILEX-G 400 is not indicated in the management of status asthmaticus, which is a serious medical emergency. Although the relationship between plasma levels of dyphylline and appearance of toxicity is unknown, excessive doses may be expected to be associated with in increased risk of adverse effects.

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: DILEX-G 400 may cause nausea, headache, cardiac palpitation and CNS stimulation. Postprandial administration may help avoid gastric discomfort. The following adverse reactions have been reported with other xanthine bronchodilators and have been most often related to excessive drug plasma levels. They should be considered as potential adverse effects when dyphylline is administered. Gastrointestinal: nausea, vomiting, epigastirc pain, hematemesis, diarrhea. Central Nervous System: headache, irritability, restlessness, insomnia, hyperexcitability, agitation, muscle twitching, generalized clonic and tonic convulsions. Cardiovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory failure, ventricular arrhythmias. Respiratory: tachypnea. Renal: albuminuria, gross and microscopic hematuria, dieresis. Other: hyperglycemia, inappropriate ADH syndrome. There have been no serious side effects reported with the use of guaifenesin.

Reported adverse events (FAERS/openFDA)#

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