{"active_ingredient":["Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg"],"do_not_use":["Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician."],"dosage_and_administration":["Directions Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor. Children under 12: Do not use without consulting a doctor."],"effective_time":"20251117","id":"43d1e43f-1475-87b0-e063-6294a90a67ca","inactive_ingredient":["Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch."],"indications_and_usage":["Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"brand_name":["AZO Urinary Pain Relief Maximum Strength"],"generic_name":["PHENAZOPYRIDINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["i-Health, Inc."],"package_ndc":["49973-247-12","49973-247-24","49973-247-96","49973-247-06","49973-247-48"],"product_ndc":["49973-247"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094147","2048946"],"spl_id":["43d1e43f-1475-87b0-e063-6294a90a67ca"],"spl_set_id":["b4874fe2-d98b-4b5c-baad-d75070947842"],"substance_name":["PHENAZOPYRIDINE HYDROCHLORIDE"],"unii":["0EWG668W17"],"upc":["0787651241531","0787651122533"]},"other_safety_information":["Other Inf ormation 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 (59-86 F) 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."],"package_label_principal_display_panel":["Packaging RELIEF That's Fast AZO Urinary Pain Relief® MAXIMUM STRENGTH STRONGEST UTI PAIN RELIEVER AVAILABLE+ EVEN HIGHER DOSE TO RELEIVE PAIN, BURNING & URGENCY+ TARGETS THE SOURCE OF PAIN #1 MOST TRUSTED BRAND* __ TABLETS 99.5 mg Phenazopyridine Hydrochloride +Among AZO Urinary Pain Relief® products. * #1 Most Trusted Brand based on Total AZO Brand Nielsen data through 10/04/25 and the 2025 Pharmacy Times Survey (Urinary Pain Relief and Cranberry Supplement categories). AZO UPR 48 CT UPR 12 UPR 24 UPR English Insert UPR Spanish Insert UPR 96 UPR 96 English Insert UPR 96 Spanish Insert UPR 6"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use."],"purpose":["Purpose Urinary tract analgesic"],"set_id":"b4874fe2-d98b-4b5c-baad-d75070947842","spl_patient_package_insert":["AZO Urinary Pain Relief ® MAXIMUM STRENGTH Urinary Pain Relief Tablets Active ingredient: Each analgesic tablet contains Phenazopyridine Hydrochloride 99.5 mg. Fast relief of urinary discomfort including common urinary tract infection symptoms: Urinary pain, burning, urgency and frequency . URINARY TRACT INFECTION (UTI) Symptoms of urinary discomfort may indicate a urinary tract infection. If you experience symptoms such as urinary pain, burning, urgency and frequency, you need to call your doctor to get diagnosed and obtain a prescription to treat the infection. While you wait to get to the doctor and for the prescription to begin to work, you can get fast, symptomatic relief with AZO Urinary Pain Relief Maximum Strength . WARNINGS Ask a doctor before use if you have : liver or kidney trouble allergies to foods, preservatives or dyes had a hypersensative reaction to Phenazopyridine Hydrochloride Do Not Use : if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. When using this product stomach upset may occur. Taking 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 . Stop using ths product and ask a doctor if you think you may be having an adverse reaction to the medication or if your symptoms last for more than two days. If you are pregnant or breastfeeding , ask a healthcare professional before you use this product. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use . Keep this medication out of the reach of children . In case of an overdose, get medical help or contact a Poison Control Center right away. DIRECTIONS Adults and children 12 years and older : Take two (2) tablets three (3) times daily for up to two days. Take with a full glass of water, with or after meals as needed. Do not use for more than two days (12 tablets) without consulting a doctor. Children under age 12 : do not use without consulting a doctor. OTHER INFORMATION & PRECAUTIONS This product can interfere with laboratory tests including urine, glucose (sugar) and keytones. This product may stain soft contact lenses and other items if handled after touching tablets. Size and color of tablets may vary. Carcinogenesis : 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. Storage : Store at room temperature (59° - 86°F) 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 damanged. For questions, concerns, or to report an adverse event, please call (800) 722-3476 or visit www.azoproducts.com AZO Urinary Pain Relief ® MAXIMUM STRENGTH Alivio rápido para el dolor de las vías urinarias Ingrediente activo: Cada tableta de analgésico contiene 99.5 mg de hidrocloruro de fenazopiridina. Alivio rápido de la incomodidad en las vías urinarias que incluye los síntomas comunes de infección en las vías urinarias: dolor al orinar, ardor, urgencia y frecuencia. INFECCIÓN DE LAS VÍAS URINARIAS Los síntomas de incomodidad en las vías urinarias pueden indicar la presencia de una infección. Si tiene síntomas como dolor, ardor, urgencia y frecuencia, necesita llamar a su médico para recibir un diagnóstico y que le dé una receta para tratar la infección. Mientras espera para ver al doctor y para que el medicamento que le recete comience a funcionar, puede obtener un alivio rápido de sus síntomas con AZO Urinary Pain Relief® Maximum Strength. ADVERTENCIAS Consulte a su médico antes de usar este producto si : • tiene problemas renales o hepáticos. • tiene alergias a alimentos, conservadores o tintes. • ha tenido una reacción alérgica a el hidrocloruro de fenazopiridina. No usar : si tiene una deficiencia de glucosa-6-fosfato deshidrogenasa (G6PD), a menos que su médico lo apruebe. Al usar este producto: • puede sentir malestar estomacal. Tómelo durante o después de las comidas para ayudar a disminuir el malestar. • la orina adquiere un color anaranjado rojizo. Esto no es dañino, pero debe tener cuidado para evitar manchar a ropa u otros artículos. Deje de usar este producto y consulte a su médico si piensa que puede estar teniendo una reacción adversa al medicamento o si sus síntomas duran más de dos días. Si usted está embarazada o lactando , consulte a un profesional médico antes de usar este producto. Se recomienda una prueba de embarazo y una consulta con un profesional médico si se confirma un embarazo antes de usar el producto. Mantenga este medicamento fuera del alcance de los niños . En caso de una sobredosis, consiga atención médica o comuníquese con un centro de control de envenenamiento de inmediato. INSTRUCCIONES Adultos y niños mayores de 12 año s: tome dos (2) tabletas tres (3) veces al día hasta dos días. Tome con un vaso de agua, durante o después de las comidas, según sea necesario. No lo utilice durante más de 2 días (12 tabletas) sin consultar a un médico. Niños menores de 12 años : no se utilice sin consultar a un médico. OTRA INFORMACIÓN y PRECAUCIONES • Este producto puede interferir con los análisis de laboratorio, incluso los análisis de orina, glucosa (azúcar) y cetonas. • Este producto puede manchar los lentes de contacto blandos y otros artículos si los manipula después de tocar las tabletas. • El tamaño y el color de las tabletas puede variar. • Carcinogénesis : la administración a largo plazo del hidrocloruro de fenazopiridina ha inducido neoplasia en ratas (intestino grueso) y ratones (hígado). Aunque no se ha informado acerca de ningún caso que relacione el hidrocloruro de fenazopiridina con la neoplasia en humanos, no se han efectuado estudios epidemiológicos adecuados al respecto. • Almacenaje : almacénese a temperatura ambiental (15° a 30°C) en un sitio seco, y protéjase de la luz. • Evidencia de alteraciones: el producto viene sellado en blísteres. No lo use si alguna parte del blíster está rota, abierta o dañada. Para preguntas, dudas o para informar acerca de una reacción adversa, llame al (800) 722-3476 o visite www.azoproducts.com"],"spl_product_data_elements":["AZO Urinary Pain Relief Maximum Strength Phenazopyridine Hydrochloride MICROCRYSTALLINE CELLULOSE STARCH, CORN HYPROMELLOSE, UNSPECIFIED POVIDONE, UNSPECIFIED CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL, UNSPECIFIED CARNAUBA WAX MAGNESIUM STEARATE PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE Maroon 99"],"spl_unclassified_section":["Distributed by i-Health, Inc., 25 Bacon Road, Enfield, CT 06082 Made in India. Size and color of tablets may vary. For questions, concerns, or to report an adverse event, call (800) 722-3476 AZO Urinary Pain Relief ® and OWN YOUR DAY™ are trademarks of DSM. Información y instrucciones en Español adjuntas visit www.azoproducts.com to read customer reviews"],"stop_use":["Stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication."],"version":"11","warnings":["Warnings Please read insert for important precautions. 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 if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. When using this product 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. Stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication. If pregnant or breastfeeding, ask a professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product 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."]}