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Cystex is an oral over-the-counter combination urinary analgesic and antibacterial product used for temporary relief of symptoms associated with urinary tract infection and bladder irritation, including dysuria, urgency, and frequency. It contains two **small-molecule** active ingredients: methenamine, which serves as a urinary antibacterial agent by decomposing in acidic urine to generate formaldehyde with nonspecific antimicrobial activity, and sodium salicylate, a nonsteroidal anti-inflammatory drug that provides analgesic effects through cyclooxygenase inhibition and reduced prostaglandin synthesis. The product has been distributed under the Cystex brand by Cystex and labeled by Clarion Brands, and is marketed as a dual-action formula without urine-discoloring agents. Based on the provided context, its labeling has not been approved by the FDA and the product has not been found by FDA to be safe and effective.
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