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DISPENSE contents with a child-resistant closureas requiredand in a tight container as defined in the USP.
This is not a complete list of side effects and others may occurCall your doctor for medical advice about side effectsYou may report side effects to FDA at 1-800-FDA-1088.
Headacherashpruritus and occasional gastrointestinal disturbanceAt anaphylactoid-like reaction has been describedMethemoglobinemiahemolytic anemiarenal and hepatic toxicity have been reportedusually at overdosage levelssee OVERDOSAGE section
Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HClThere arehoweverno adequate and well controlled studies in pregnant womenBecause animal reproduction studies are not always predictive of human responsethis drug should be used during pregnancy only if clearly needed.
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although no association between pyridium hcl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.