Drug Facts
Active ingredient (in each tablet)
Methenamine 162 mg
Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Uro-pain Dual Action (NDC 57237-332). 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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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:
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:
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you are:
When using this product: do not take more than the recommended dosage
Stop and ask a doctor if:
If pregnant or breastfeeding, ask a health professional before use.
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
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750
Issued: 09/2023
* Please review the disclaimer below.