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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.