FDA label 16d90466-c499-3976-e063-6394a90a3db0
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
- e49a93a8-158a-4184-b4bc-cac3031ad8b6
- SPL ID
- 16d90466-c499-3976-e063-6394a90a3db0
- Version
- 7
- Effective date
- 2024-04-24
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:36:56
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 | 16d90466-c499-3976-e063-6394a90a3db0 | id | |
| spl set id | e49a93a8-158a-4184-b4bc-cac3031ad8b6 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Interaction with other drugs: Intensifies the effect of MAO inhibitors, sedative preparations, ethanol. The risk of the hepatotoxic action of paracetamol increases during concurrent use of barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, and other hepatic microsomal enzyme inducers. Antidepressants, antiparkinsonian agents, antipsychotic agents, and phenothiazine derivatives - increase the risk of developing urinary retention, dry mouth, and constipation. Glucocorticosteroids increase the risk of developing elevated intraocular pressure.
warnings and cautions
Special warnings: To avoid toxic liver damage, the preparation should not be combined with the use of alcoholic beverages. Care should be taken when the preparation is used by individuals over 70 years of age with cardiovascular disease because of the possible vasoconstricting action of phenylephrine. If regardless of the use of the preparation, the illness is accompanied by continuing fever or repeated temperature elevations, a physician must be consulted. Do not exceed the recommended dose. Do not use the preparation from damaged packets. Effect on the ability to drive an automobile and to operate machinery. During treatment, care must be taken when operating an automobile or other machinery, requiring mental alertness and quick psychomotor reactions.
warnings and cautions
Effect on the ability to drive an automobile and to operate machinery. During treatment, care must be taken when operating an automobile or other machinery, requiring mental alertness and quick psychomotor reactions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Side effects: possible allergic reactions (skin rash, pruritus, hives, angioedema), hyperexcitability, sleep disorder, reduction in the speed of psychomotor reactions, drowsiness, dizziness, nausea, vomiting, stomach pain, palpitations, blood pressure increase, dry mouth, accommodative palsy, increase in intraocular pressure, urinary retention. During prolonged use in high doses - hepatotoxic action, changes in blood count; nephrotoxicity.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.