Maximum Strength Urinary Pain Relief

Maximum Strength Urinary Pain Relief is an FDA drug label for the active ingredient PHENAZOPYRIDINE HYDROCHLORIDE manufactured by KROGER COMPANY administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231230.

Generic: PHENAZOPYRIDINE HYDROCHLORIDE

Manufacturer: KROGER COMPANY

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 30142-756

Application:

Effective: 20231230

Active Ingredients: Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg

Indications & Usage

Uses Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Dosage & Administration

Directions Adults and children 12 years and over: 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 years: Do not use without consulting a doctor

Contraindications

Not available.

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 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.

Adverse Reactions

Not available.

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