methenamine, sodium salicylate

FDA Drug Profile — Cystex Plus, Cystex

Drug Details

Generic Name
methenamine, sodium salicylate
Brand Names
Cystex Plus, Cystex
Application Number
505G(a)(3)
Sponsor
Clarion Brands, LLC
NDC Codes
3
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
METHENAMINE, SODIUM SALICYLATE

Indications and Usage

Uses Temporarily relieves: pain & burning • frequency and urgency of urination

Warnings

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you: • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) • have 3 or more alcoholic drinks every day while using this product • have stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • take more or for a longer time than directed Do not use: • if you are on a sodium restricted diet • if you are allergic to salicylates (including aspirin) unless directed by a doctor • if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor Ask a doctor before use if you have • frequent, burning urination for the first time • the stomach bleeding warning applying to you • history of stomach problems, such as heartburn • high blood pressure • heart disease • liver cirrhosis • bleeding problems • diuretic use • ulcers • kidney disease • reached age 60 or older Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug When using this product • do not take more than the recommended dosage Stop and ask a doctor if • product has been used for 3 days • you experience any of the following signs of stomach bleeding: • feel faint, vomit blood • have bloody or black stools • have stomach pain that does not get better • ringing in the ears or a loss of hearing occurs If pregnant or breast feeding, ask a health professional before use.