Uro-pain Dual Action

Uro-pain Dual Action
SPL v1
SPL
SPL Set ID f8ff15be-e537-4acc-a6e6-5934ff8b48ae
Route
ORAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methenamine (162 mg) Salicylic Acid (162.5 mg)
Inactive Ingredients
Benzoic Acid Powdered Cellulose Croscarmellose Sodium Ferrosoferric Oxide Fd&c Red No. 40 Fd&c Yellow No. 6 Hydroxypropyl Cellulose (1600000 Wamw) Hypromelloses Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Silicon Dioxide Stearic Acid Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-06

Description

Active ingredient (in each tablet) Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)


Medication Information

Indications and Usage

Uses

Temporarily relieves:

  • pain & burning
  • frequency and urgency of urination
Dosage and Administration

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

Description

Active ingredient (in each tablet) Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)

Section 42228-7

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

Section 50565-1

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

Section 50566-9

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
Section 50567-7

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

Section 50568-5

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 
Section 50569-3

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
Section 50570-1

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
Section 51727-6

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

Section 51945-4

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.

Section 55105-1

Purpose

Antibacterial

Analgesic (pain reliever)

Section 60561-8

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
Drug Facts

Active ingredient (in each tablet)

Methenamine 162 mg

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

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 
Questions Or Comments? Call 1 844 474 7464
Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg License Code:

RA/Drug/RAJ.-1750

Issued: 09/2023


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves:

  • pain & burning
  • frequency and urgency of urination
Dosage and Administration (34068-7)

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

Section 42228-7 (42228-7)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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 
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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.

Section 55105-1 (55105-1)

Purpose

Antibacterial

Analgesic (pain reliever)

Section 60561-8 (60561-8)

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
Drug Facts

Active ingredient (in each tablet)

Methenamine 162 mg

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

warnings (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 
Questions Or Comments? Call 1 844 474 7464 (Questions or comments? Call 1-844-474-7464)
Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg License Code:

RA/Drug/RAJ.-1750

Issued: 09/2023


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