FDA.reportPublic FDA data

URO-PAIN Dual Action

Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:11

Label at a glance#

ProductURO-PAIN Dual Action Antibacterial Protection
Active ingredientMETHENAMINE, SODIUM SALICYLATE
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Methenamine 162 mg

Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)

OTC - PURPOSE SECTION

Purpose

Antibacterial

Analgesic (pain reliever)

INDICATIONS & USAGE SECTION

Uses

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

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 heartburn
  • 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 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 bloody or black stools, have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs

PREGNANCY SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other Information:

  • each tablet contains 25 mg of sodium
  • store at 59°-86°F (15°-30°C) in a dry place
  • protect from light
  • Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged

INACTIVE INGREDIENT SECTION

Inactive Ingredients: benzoic acid, cellulose, croscarmellose sodium, edible black ink, fd & c red #40 lake, fd & c yellow #6 lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, silica, stearic acid, titanium dioxide, triethyl citrate

Questions or comments? Call 1-844-474-7464

OTC - QUESTIONS SECTION

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750

Issued: 09/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Case Label NDC 57237-332-42

URO-PAIN Dual Action

Antibacterial Urinary Pain Relief

Methenamine and Sodium Salicylate (NSAID) Tablets
162 mg; 162.5 mg

* Helps inhibit the progression of infection until you see your healthcare professional. URO is not intended to replace medical care.

uro-pain-label01uro-pain-label01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSN1
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCD1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-332-42URO-PAIN Dual ActionAntibacterial Protection24 in 1 BLISTER PACKTABLET241
57237-332-42URO-PAIN Dual ActionAntibacterial Protection1 in 1 BOXTABLET11
57237-332-81URO-PAIN Dual ActionAntibacterial Protection1 in 1 BOXTABLET11
57237-332-81URO-PAIN Dual ActionAntibacterial Protection18 in 1 BLISTER PACKTABLET181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-332URO-PAIN DUAL ACTION ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20240113_f8ff15be-e537-4acc-a6e6-5934ff8b48ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-332-42EA - Each57237-332a4a53466-c0f9-48e5-9c45-b64f6a5f5f4712024-03-12

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
57237-33257237-332-42, 57237-332-81

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
METHENAMINEJ50OIX95QVACTIB
SODIUM SALICYLATEWIQ1H85SYPACTIB
BENZOIC ACID8SKN0B0MIMIACT
POWDERED CELLULOSESMD1X3XO9MIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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
URO-PAIN Dual Action Antibacterial ProtectionMETHENAMINE, SODIUM SALICYLATERising Pharma Holdings, Inc.f8ff15be-e537-4acc-a6e6-5934ff8b48ae2023-12-28WarningsExact identifier
ndc (package): 57237-332-81
ndc (package): 57237-332-42
ndc (product): 57237-332
ndc11 (package): 57237033281
ndc11 (package): 57237033242
spl id: 7de0855a-1d70-49b9-85a2-d25806e13f20
spl set id: f8ff15be-e537-4acc-a6e6-5934ff8b48ae

Reported adverse events (FAERS/openFDA)#

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