openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Caution: If pain persist for more than 10 days, or if redness is present, consult a physical immediately. Acetaminophen in massive overdosage may cause hepatotoxity in some patients. Phenyltoloxamine citrate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder-neck obstruction. This compkund 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 Flextra TM Plus 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 hearbeat.
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. Phenyltoloxamine Citrate - urticaria, drowsiness, disturbed coordination, inhability 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 hyperglycemia.