FDA label 72a2d121-c42a-4313-911f-6886335ef602

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
72a2d121-c42a-4313-911f-6886335ef602
SPL ID
72a2d121-c42a-4313-911f-6886335ef602
Version
1
Effective date
2011-03-14
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:08

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 physician immediately. Children and tOORagefSshoold not use this medication 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 palients (see OVERDOSAGE). Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. In rare instances, the use of magnesium salicylate 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. The recommended dose for Durabac TM Forte Tablets contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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, thrombocylopenia, and agranulocytosis. Magnesium salicylate -dose-related G1 and CNS disturbances are the most common adverse effects of magnesium salicylate. G1 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, thromoocytopenia purpura, and mild salicylism have also been reported. Adverse G1 and CNS effects occur infrequently with magnesium salicylate doses of 325-650 mg but occur often with higher 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. Caffeine - cardiac stimulation, irritability, tremor, dependence, nephrotoxicity and hyperglicemia.

Reported adverse events (FAERS/openFDA)#

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