Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 99.5 mg .
Uqora Maximum Uti Pain Relief Tablet
FDA Label NDC 73712-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bonafide Health, Llc Dba Uqora for the product Uqora Maximum Uti Pain Relief (NDC 73712-114). 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 active ingredient (in each tablet), purpose, use, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Urinary Tract Analgesic
Use
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.
Warnings
Do not exceed recommended dosage
Otc - Do Not Use
Do not use: if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Otc - Ask Doctor
Ask doctor before use if you have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine
Otc - When Using
When using this product
■ stomach upset may occur, taking this product with or after meals may reduce stomach upset
■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
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■ Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) andmice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has beenreported, adequate epidemiological studies along these lines have not been conducted.
Otc - Stop Use
Stop use and ask doctor if
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.
Directions
Adults and children 12 years and over:
■ take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Do not use for more than 2 days (12 tablets) without consulting a doctor.
Children under 12 years:
■ consult a doctor
Other Information
■ this product may stain contact lenses ■ this product can interfere with laboratorytests including urine, glucose (sugar), and ketones tests ■ store at room temperature 15°-30°C (59°-86°F) in adry place and protect from light ■ Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal isopen or damaged
Inactive Ingredients
corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodiumstarch glycolate, talc and triacetin
Package Label.Principal Display Panel
MAX STRENGTH MOST POWERFUL DOSE WITHOUT RX
uqora
FOUNDED BY A UTI SUFFERER
UTI PAIN RELIEF
MAX STRENGTH
FAST TARGETED RELIEF FOR
Burning
Pain & discomfort at the source unlike general pain relievers
Urgency
2 Day Supply
12 tablets
99.5 mg Phenazopyridine Hydrochloride
Not intended to replace medical care
* Please review the disclaimer below.
