Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 99.5 mg .
Cheeky Bonsai Uti Pain Relief Tablet
FDA Label NDC 81860-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ixxa, Inc for the product Cheeky Bonsai Uti Pain Relief (NDC 81860-113). 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
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
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
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.
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
Corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and triacetin.
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
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