Nuvicare-urinary Tract Defense Tablet
FDA Label NDC 84324-041

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Nuvicare-urinary Tract Defense (NDC 84324-041). 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 ingredients (in each tablet), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Methenamine 162 mg

Sodium Salicylate 162.5 mg (NSAID Non steroidal anti-inflammatory drug)

Purpose

Methenamine ................................................................................................................................ Antibacterial
Sodium Salicylate (NSAID Non steroidal anti-inflammatory drug).................................. Analgesic (pain reliever)

Uses

Temporarily relieves:

■Pain & burning ■ frequency and urgency of urination

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

■ have 3 or more alcoholic drinks every day while using this product

■ have stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug

■are age 60 or older

■take more or for a longer time than directed

Directions

Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids.

Children under 12 years: ask a doctor.

Other Information

■ each tablet contains 23.76 mg of sodium

■ store at 59°F-86°F (15°C-30°C) in a dry place

■ protect from light

Inactive Ingredients

benzoic acid, croscarmellose sodium, FD&C red number 40 lake, FD&C yellow number 6 lake, ferrosoferric oxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, powdered cellulose, silicon dioxide, stearic acid, titanium dioxide, triethyl citrate

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