Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 99.5 mg .
Stix Maximum Strength Urinary Pain Relief Tablet
FDA Label NDC 80584-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Get Stix Inc. for the product Stix Maximum Strength Urinary Pain Relief (NDC 80584-113). 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 (in each tablet), purpose, warnings, ask doctor before use if you have, when using this product, stop use and ask doctor if, if pregnant or breast feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Urinary Analgesic
Warnings
Do not exceed recommended dosage
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to food, 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 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.
Keep Out Of Reach Of Children
In case of an overdose, get medical help or contact a Poison Control Center right away.
Use
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
infections.
Inactive Ingredients
Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.
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
Package Label.Principal Display Panel
Image Of Carton (Qcmax0001)
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