Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Healthmart Urinary Pain Relief Tablet
FDA Label NDC 62011-0325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Healthmart Urinary Pain Relief (NDC 62011-0325). 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.
Label Section Quick Index
Purpose
Urinary Analgesic
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Warning
Do not exceed recommended dosage
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
When Using This Product
■ 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
If Pregnant Or Breast Feeding
ask a health professional before use.
Keep Out Of The Reach Of Children
in case of an overdose,get medical help or contact a Poison Control Center right away.
Directions
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Inactive Ingredients
lactose, magnesium silicate, magnesium stearate, microcrystalline
cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,
croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.
Package Label.Principal Display Panel
Image Of Carton (Carton)
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