openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS If pain persists for more than 10 days, or if redness is present, consult a physician immediately. Children and teenagers should 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 patients (see OVERDOSAGE). 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. The recommended dose for Durabac Capsules 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.
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, leukopenia, 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. Caffeine· cardiac stimulation, irritability, tremor, dependence, nephrotoxity and hyperglycemia.