Uristat Ultra

Drug Facts

Composition & Product

Active Ingredients

Phenazopyridine (99.5 mg)

Inactive Ingredients

Citric Acid Monohydrate Croscarmellose Sodium Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Mineral Oil Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: X Shape: round Color: brown Size: 7 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2018-02-15

Medication Information

Purpose

Urinary analgesic

Description

URISTAT ® ULTRA Phenazopyridine Hydrochloride 99.5 mg Drug Facts

1-800-344-7239 Uristat.com

Use

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

Section 42229-5

URISTAT ® ULTRA

Phenazopyridine Hydrochloride 99.5 mg

Drug Facts

Warnings

Do not exceed recommended dosage

Directions

Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
Children under 12 years of age: consult a doctor.
Do not use for more than 2 days (12 tablets) without consulting a doctor

Other Information

This product may stain contact lenses
This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
Long term administration of phenazopyridine HCl 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
Store at 20º-25º C (68º-77º F) in a dry place and protect from light.

Inactive Ingredients

citric acid, artificial & natural cranberry flavor, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica, starch, and sucralose.

Principal Display Panel

URISTAT ^® ULTRA with Cranberry flavored coating

UTI Pain Relief Tablets

Phenazopyridine Hydrochloride 99.5 mg

30 Urinary Pain Relief Tablets

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.

Stop Use and Ask A Doctor If

your symptoms last for more than 2 days
you suspect you are having an adverse reaction to the medication
experience a yellowish tinge of skin or eyes
experience fevers chills, back pain or bloody urine

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Phenazopyridine hydrochloride 99.5 mg

Ask A Doctor Before Use If You Have

kidney disease
allergies to foods, preservatives, or dyes
had a hypersensitive reaction to phenazopyridine

Structured Label Content

1-800-344-7239 Uristat.com

Use

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

Section 42229-5 (42229-5)

URISTAT ® ULTRA

Phenazopyridine Hydrochloride 99.5 mg

Drug Facts

Purpose

Urinary analgesic

Warnings

Do not exceed recommended dosage

Directions

Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
Children under 12 years of age: consult a doctor.
Do not use for more than 2 days (12 tablets) without consulting a doctor

Other Information (Other information)

This product may stain contact lenses
This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
Long term administration of phenazopyridine HCl 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
Store at 20º-25º C (68º-77º F) in a dry place and protect from light.

Inactive Ingredients (Inactive ingredients)

citric acid, artificial & natural cranberry flavor, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica, starch, and sucralose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

URISTAT ^® ULTRA with Cranberry flavored coating

UTI Pain Relief Tablets

Phenazopyridine Hydrochloride 99.5 mg

30 Urinary Pain Relief Tablets

When Using This Product (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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

your symptoms last for more than 2 days
you suspect you are having an adverse reaction to the medication
experience a yellowish tinge of skin or eyes
experience fevers chills, back pain or bloody urine

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

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 (1-800-222-1222) right away.

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

Phenazopyridine hydrochloride 99.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease
allergies to foods, preservatives, or dyes
had a hypersensitive reaction to phenazopyridine

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information