FDA label 5fdd10b4-326f-4780-ae2e-625553ddc47b

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
5fdd10b4-326f-4780-ae2e-625553ddc47b
SPL ID
5fdd10b4-326f-4780-ae2e-625553ddc47b
Version
1
Effective date
2011-03-15
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 02:21:33

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Caution: If pain persists for more than 10 days, or if redness is present, consult a physical immediately. Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye syndrome, a rare but serious illness. Acetaminophen in massive overdosage may cause hepatotoxicity in some patients. Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. In rare instances, the use of salicylamide in persons allergic to salicylates can result in life-threatening allergic episodes. Phenyltoloxamine citrate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder neck obstruction. This compound has an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, cardiovascular disease or hypertension.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The following adverse reactions have been reported for each of the individual components or combinations of ingredients. Acetaminophen - urticaria, epigastric distress, dizziness, palpitations, allergic reactions, rash, thrombocytopenia and agranulocytosis. Salicylamide - dose - related GI and CNS disturbances are the most common adverse effects of salicylamide. GI disturbances may include nausea, vomiting, heartburn, anorexia, or diarrhea. CNS disturbances may include dizziness, drowsiness, lightheadedness, faintness, or headache. Flushing hyperventilation, sweating, dry mouth, rash, thrombocytopenia purpura, and mild Salicylism have also been reported. Adverse GI and CNS effects occur infrequently with salicylamide doses of 325-650 mg but occur often with higher doses. Tinnitus, ecchymoses, hemorrhagic lesions, leucopenia, or thrombocytopenia may also occur with high doses. Phenyltoloxamine citrate - urticaria, drowsiness, disturbed coordination, inability to concentrate, dizziness, insomnia, tremors, nervousness, palpitation, convulsions, muscular weakness, gastric distress, diarrhea, intestinal cramps, blurred vision, hypotension, urinary retention, dryness of mouth, throat and nose, xerostomia and nausea.

Reported adverse events (FAERS/openFDA)#

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