Active Ingredient
Phenazopyridine Hydrochloride 95 mg
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Neighbor Pharmacy Urinary Pain Relief (NDC 70677-1229). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warning, ask doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Phenazopyridine Hydrochloride 95 mg
Urinary Analgesic
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Do not exceed recommended dosage
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
■ 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.
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
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.
ask a health professional before use.
in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.
■ 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
■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light
lactose, corn starch, croscarmellose sodium, microcrystalline
cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate,
pregelatinized starch, silicon dioxide, talc, and triacetin.
* Please review the disclaimer below.