Drug Facts

Composition & Product

Active Ingredients

Phenazopyridine (99.5 mg)

Inactive Ingredients

Lactose Magnesium Silicate

Identifiers & Packaging

Pill Appearance

Shape: oval Color: brown Size: 9 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-09-20

Medication Information

Purpose

Urinary Analgesic

Description

Phenazopyridine Hydrochloride 99.5 mg .

Use

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

infections.

Section 51945-4

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

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Inactive Ingredients

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

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 Doctor If

■ your symptoms last for more than 2 days

■ you suspect you are having an adverse reaction to the medication

Keep Out of Reach of Children

In case of an overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Ask Doctor Before Use If You Have

■ kidney disease

■ allergies to food, preservatives or dyes

■ had a hypersensitive reaction to phenazopyridine

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.

Section 51945-4 (51945-4)

Purpose

Urinary 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

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Inactive Ingredients (Inactive ingredients)

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

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 Doctor If (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

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.

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

Ask a health professional before use.

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

■ kidney disease

■ allergies to food, preservatives or dyes

■ had a hypersensitive reaction to phenazopyridine

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

Phenazopyridine Hydrochloride 99.5 mg .

Advanced Ingredient Data

[{"name": "PHENAZOPYRIDINE", "unii": "K2J09EMJ52", "classCode": "ACTIB", "strengthNumerator": "99.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SILICATE", "unii": "9B9691B2N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.", "Purpose": "Urinary 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 ■ children under 12 years: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor", "Inactive ingredients": "Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.", "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 doctor if": "■ your symptoms last for more than 2 days ■ you suspect you are having an adverse reaction to the medication", "Keep out of reach of children": "In case of an overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast feeding,": "Ask a health professional before use.", "Ask doctor before use if you have": "■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine", "Active ingredient (in each tablet)": "Phenazopyridine Hydrochloride 99.5 mg ."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information