URO-PAIN DUAL ACTION ANTIBACTERIAL PROTECTION- methenamine, sodium salicylate tablet 
Rising Pharma Holdings, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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URO-PAIN Dual Action

Drug Facts

Active ingredient (in each tablet)

Methenamine 162 mg

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

Purpose

Antibacterial

Analgesic (pain reliever)

Uses

Temporarily relieves:

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:

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

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

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 

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

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

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

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

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:

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

Distributed by:

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

Issued: 09/2023

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-label01

URO-PAIN DUAL ACTION  ANTIBACTERIAL PROTECTION
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-332
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE162 mg
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE162.5 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code URO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-332-421 in 1 BOX12/06/2023
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:57237-332-811 in 1 BOX12/06/2023
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/06/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 12/2023
Document Id: 7de0855a-1d70-49b9-85a2-d25806e13f20
Set id: f8ff15be-e537-4acc-a6e6-5934ff8b48ae
Version: 1
Effective Time: 20231228
 
Rising Pharma Holdings, Inc.