Uqora Maximum Uti Pain Relief

Uqora Maximum Uti Pain Relief
SPL v1
SPL
SPL Set ID 426317e7-a925-116a-e063-6294a90a52dc
Route
ORAL
Published
Effective Date 2025-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (99.5 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Starch, Corn Silicon Dioxide Croscarmellose Sodium Sodium Starch Glycolate Type A Talc Povidone Hypromellose, Unspecified Microcrystalline Cellulose Triacetin Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: p99 Shape: oval Color: brown Size: 9 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-10-27

Description

Phenazopyridine Hydrochloride 99.5 mg .

Purpose

Urinary Tract Analgesic


Medication Information

Purpose

Urinary Tract Analgesic

Description

Phenazopyridine Hydrochloride 99.5 mg .

Use

Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.

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 1-800-222-1222.

Section 50566-9

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

Section 50567-7

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.

----

■ 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.

Section 50569-3

Ask doctor before use if you have

■ kidney disease

■ allergies to foods, preservatives or dyes

■ had a hypersensitive reaction to phenazopyridine

Section 50570-1

Do not use: if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Section 51945-4

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

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Warnings

Do not exceed recommended dosage

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

Active Ingredient (in Each Tablet)

Phenazopyridine Hydrochloride 99.5 mg .


Structured Label Content

Use

Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.

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 1-800-222-1222.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.

----

■ 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.

Section 50569-3 (50569-3)

Ask doctor before use if you have

■ kidney disease

■ allergies to foods, preservatives or dyes

■ had a hypersensitive reaction to phenazopyridine

Section 50570-1 (50570-1)

Do not use: if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

Urinary Tract Analgesic

Warnings

Do not exceed recommended dosage

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 (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 (Inactive ingredients)

corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodiumstarch glycolate, talc and triacetin

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenazopyridine Hydrochloride 99.5 mg .


Advanced Ingredient Data


Raw Label Data

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