Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6
Route
ORAL
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (95 mg)
Inactive Ingredients
Starch, Corn Cellulose, Microcrystalline Croscarmellose Sodium Hypromellose, Unspecified Sodium Starch Glycolate Type A Corn Lactose Magnesium Stearate Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Talc Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: P95 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-07

Description

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary Analgesic


Medication Information

Purpose

Urinary Analgesic

Description

Phenazopyridine Hydrochloride 95 mg

Uses

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

Section 51945-4

Warning

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

Active Ingredient

Phenazopyridine Hydrochloride 95 mg

Other Information



■ this product may stain contact lenses

■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test

■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light

Inactive Ingredients

lactose, corn starch, croscarmellose sodium, microcrystalline

cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, 

pregelatinized starch, silicon dioxide, 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 A 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.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask Doctor Before Use If You Have



■ kidney disease

■ allergies to foods, preservatives or dyes

■ had a hypersensitive reaction to Phenazopyridine

Keep Out of the Reach of Children

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


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

Urinary Analgesic

Warning

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

Active Ingredient

Phenazopyridine Hydrochloride 95 mg

Other Information



■ this product may stain contact lenses

■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test

■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light

Inactive Ingredients

lactose, corn starch, croscarmellose sodium, microcrystalline

cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, 

pregelatinized starch, silicon dioxide, talc, and triacetin.

When Using This Product (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  

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.

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 foods, preservatives or dyes

■ had a hypersensitive reaction to Phenazopyridine

Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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