Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 97ea2a3e-c1a0-437d-ac2a-2128e193183b
Route
ORAL
Published
Effective Date 2023-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: oval Color: brown Size: 9 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-07-20

Description

Phenazopyridine Hydrochloride 99.5 mg .

Purpose

Urinary Analgesic


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

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

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

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

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

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 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

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

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)

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

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

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 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


Raw Label Data

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