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
- 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
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 | 449ed61a-a26b-4c38-8adc-59f8b190f43c | id | |
| spl set id | 016df73a-74a0-4ad0-a040-3d18c049aca3 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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
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.