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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Bonafide Health, Llc Dba Uqora for the product Uqora Antibacterial Plus Urinary Pain Relief (NDC 73712-804). 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 other, otc - purpose, uti infection control, uti pain relief, reye's syndrome (uti infection control only), stomach bleeding warning (uti infection control only), do not exceed (uti pain relief only), do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each tablet) | Purpose |
| Methenamine 162mg | Antibacterial |
Sodium Salicylate 162.5mg (NSAID)* *nonsteroidal anti-inflammatory drug | Analgesic (pain reliever) |
Active ingredient (in each tablet) | Purpose |
| Phenazopyridine Hydrochloride 99.5mg | Urinary Tract Analgesic |
Temporarily relieves:
If pregnant or breast feeding,ask a health professional before use. It is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Adults and children 12 years and over:
|
| Children under 12 years: ask a doctor. |
benzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.
If pregnant or breast feeding,ask a health professional before use.
Adults and children 12 years and over:
|
| Children under 12 years:consult a doctor |
corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and triacetin.
Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this
product. When using 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you
Do not exceed recommended dosage
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:
Stop use and ask a doctor if:
Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although
no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222
Distributed by Uqora, Inc.
3043 4th Avenue, San Diego, CA 92103
For questions or concerns please contact (888) 313-1372
2 diagnostic UTI test strips(Directions Enclosed)
Other information
uqora
Urinary Care
Maximum Strength UTI Pain Relief Included
ALL-IN-ONE
UTI EMERGENCY KIT
2 Day Supply Includes:
Test Strips
Infection Control
Max Strength Pain Relief
Packaged for convenience. Not intended to replace medical care.
* Please review the disclaimer below.