{"active_ingredient":["Active ingredient Phenazopyridine hydrochloride 99.5 mg"],"ask_doctor":["Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine hydrochloride"],"do_not_use":["Do not use if you have Glucose-6-Phosphare Dehydrogenase (G6PD) deficiency unless approved by your doctor"],"dosage_and_administration":["Directions Adults and children 12 years of age and older: take 2 tablets 3 times a day with a full glass of water or after meals as needed children under 12 years: ask a doctor"],"effective_time":"20260114","id":"485b5018-57f0-90d7-e063-6294a90ae5e2","inactive_ingredient":["Inactive ingredients corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, triacetin"],"indications_and_usage":["Use fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days without consulting a doctor; see Directions."],"keep_out_of_reach_of_children":[""],"openfda":{"application_number":["505G(a)(3)"],"brand_name":["Cystex Max UTI Pain Relief"],"generic_name":["PHENAZOPYRIDINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Clarion Brands, LLC"],"package_ndc":["69693-514-24"],"product_ndc":["69693-514"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094147"],"spl_id":["485b5018-57f0-90d7-e063-6294a90ae5e2"],"spl_set_id":["a4d34c20-62af-4a3c-ad2c-046ba08d1ef6"],"substance_name":["PHENAZOPYRIDINE HYDROCHLORIDE"],"unii":["0EWG668W17"],"upc":["0889476510240"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MAX STRENGTH Cystex ® Urinary Health Phenazopyridine Hydrochloride 99.5 mg MAX UTI PAIN RELIEF FAST-ACTING UTI PAIN RELIEF Strongest UTI Pain Relief Available for Fast-Acting Relief of Pain & Burning * √ Relief of Pain, Burning, & Urgency √ Targets Pain at the Source of the UTI STARTS WORKING IN AS LITTLE AS 15 MINUTES Cystex is not intended to replace a doctor's care. 24 Tablets TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED. 1000284 REV XX/XX REESECODE For more information on Cystex Max Strength UTI Pain Relief or other products, please visit www.cystex.com or call 844-297-8394 Distributed by: Cystex LLC 811 Broad Street, Suite 600 Chattanooga, TN 37402 ©2024 *without a prescription Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use Keep out of the reach of children . In case of overdose, get medical help or contact a Poison Control Center right away."],"purpose":["Purpose Urinary tract analgesic"],"questions":["Questions call 1-844-297-8394"],"set_id":"a4d34c20-62af-4a3c-ad2c-046ba08d1ef6","spl_product_data_elements":["Cystex Max UTI Pain Relief Phenazopyridine hydrochloride STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A TALC TRIACETIN PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE CYSTEX"],"stop_use":["Stop use and ask a doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication"],"storage_and_handling":["Other information WARNING: This product contains Phenazopyridine Hydrochloride, known to the state of California to cause cancer. this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests this product may stain soft contact lenses and other items if handled after touching tablets store at room temperature 59°F-86°F (15°C-30°C) in a dry place and protect from light Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged."],"version":"4","warnings":["Warnings Do not exceed recommended dosage Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted."],"when_using":["When using this product do not exceed recommended dosage stomach upset may occur, taking this product with or after meals may reduce stomach upset your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. do not use for more than 2 days (12 tablets) without consulting a doctor"]}