{"active_ingredient":["Active ingredient (in each tablet) Phenazopyridine Hydrochloride 97.5 mg"],"ask_doctor":["Ask a doctor before use if you have ■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician"],"dosage_and_administration":["Directions ■ adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ children under 12 years: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor"],"effective_time":"20250514","id":"4fc74997-e88c-4774-983c-59ba3bcefca6","inactive_ingredient":["Inactive Ingredients corn starch, croscarmellose sodium, hypromellose, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide and sodium starch glycolate."],"indications_and_usage":["Use fast 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":{},"other_safety_information":["Other information ■ this product may stain contact lenses ■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests ■ long term administration of phenazopyridine HCl 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. ■ store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light."],"package_label_principal_display_panel":["Principal Display Panel NDC 49781-139-12 LEADER® Compare to AZO Urinary Pain Relief™ Maximum Strength* active ingredient MAXIMUM STRENGTH Urinary Pain Relief Phenazopyridine HCl 97.5 mg Fast Relief for Urinary Pain Prompt Relief of Urinary Pain, Burning & Urgency More Active Ingredient for Maximum Relief SATSIFACTION GUARANTEED 12 TABLETS 97.5mg carton"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use."],"purpose":["Purpose Urinary Analgesic"],"questions":["Questions or Comments Call 1-800-200-6313, weekdays, 9am-4pm EST"],"set_id":"f1848274-1079-412a-ba7c-1376663d8bb1","spl_product_data_elements":["Leader Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM MAGNESIUM SILICATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A P97"],"spl_unclassified_section":["*This product is not manufactured or distributed by i-Health, Inc., distributor of AZO Urinary Pain Relief™ Maximum Strength. All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund. Distributed By: Cardinal Health Dublin, Ohio 43017 www.myleader.com CIN 5087333 Rev. 5/15 AMAXLDR"],"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"],"version":"3","warnings":["Warnings Do not exceed recommended dosage Ask a doctor before use if you have ■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine Caution: Do not use this product 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 a doctor if ■ your symptoms last for more than 2 days ■ you suspect you are having an adverse reaction to the medication If pregnant or breast feeding, ask a health 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."]}