Foster And Thrive Neighbor Pharmacy Urinary Pain Relief Tablet
FDA Label NDC 70677-1229

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 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.

Active Ingredient

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary Analgesic

Uses

fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

Warning

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 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  

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 The Reach Of Children

in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.

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

Other Information


■ 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

Inactive Ingredients

lactose, corn starch, croscarmellose sodium, microcrystalline

cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, 

pregelatinized starch, silicon dioxide, talc, and triacetin.

Package Label.Principal Display Panel

Image Of Carton (Carton)

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