openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
Warnings Do not exceed recommended dosage Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. Ask a doctor before use if you have • kidney disease • allergies to foods, preservatives or dyes • had a hypersensitive reaction to Phenazopyridine Hydrochloride 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. Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. If pregnant or breastfeeding , 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.