Nuvicare-Urinary Tract Defense

Manufacturer
NUVICARE LLC
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-12 01:01:16

Label at a glance#

ProductNuvicare-Urinary Tract Defense
Active ingredientMETHENAMINE, SODIUM SALICYLATE
Label structure17 sections

Indications and uses

Temporarily relieves: ■Pain & burning ■ frequency and urgency of urination

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Methenamine 162 mg

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

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:

■Pain & burning ■ frequency and urgency of urination

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use: if you are on a sodium restricted diet

■ if you are allergic to salicylates (including aspirin) unless directed by a doctor

■ if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor

SPL UNCLASSIFIED SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

■ frequent, burning urination for the first time

■ the stomach bleeding warning applying to you

■ history of stomach problems, such as heartburnm

■ high blood pressure

■ heart disease
■ liver cirrhosis

■ bleeding problems

■ diuretic use

■ ulcers

■ kidney disease

■ reached age 60 or older

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:

■ taking any other drug containing an NSAID (prescription or nonprescription)

■ taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug

OTC - WHEN USING SECTION

When using this product: do not take more than the recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if:

■ product has been used for 3 days

■ you experience any of the following signs of stomach bleeding:

■ feel faint, vomit blood

■ have blood or black stools

■ have stomach pain that does not get better
■ ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)
right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call +1 (718) 337-8733 or email: support@nuvicare.com

SPL UNCLASSIFIED SECTION

†This product is neither manufactured nor distributed by i-Health, Inc., the distributor of AZO Urinary Tract Defense®

Distributed by: Nuvicare LLC., Brooklyn, NY 11211, U.S.A.
www.nuvicare.com

NDC 84324-041-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L206-00 NC Urinary Tract DefenseL206-00 NC Urinary Tract Defense

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-04184324-041-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nuvicare-Urinary Tract DefenseMETHENAMINE, SODIUM SALICYLATENUVICARE LLC2ea2717e-437e-4417-a09d-ea7be9d9707d2026-08-10WarningsExact identifier
ndc (package): 84324-041-01
ndc (product): 84324-041
ndc11 (package): 84324004101
spl id: 581dbaf5-b120-4818-b54f-badea68c6eb0
spl set id: 2ea2717e-437e-4417-a09d-ea7be9d9707d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.