FDA label 6bedba28-c819-4dee-b202-7539522a8580
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
- bcfe118c-5ae4-42f0-a8e0-61190bce6b68
- SPL ID
- 6bedba28-c819-4dee-b202-7539522a8580
- Version
- 1
- Effective date
- 2010-12-23
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:22:48
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 | 6bedba28-c819-4dee-b202-7539522a8580 | id | |
| spl set id | bcfe118c-5ae4-42f0-a8e0-61190bce6b68 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by your physician. Do not use this product unless a diagnosis of asthma has been made by a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a doctor. Dyphylline GG ES 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 an 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 Dyphylline GG ES 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 most often related to excessive drug plasma levels. They should be considered as potential adverse effects when dyphylline is administered: Gastrointestinal: nausea, vomiting, epigastric 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, diuresis. Other: hyperglycemia, inappropriate ADH syndrome.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.