CVS Maximum Strength Urinary Pain Relief: Package Insert and Label Information

CVS MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
CVS PHARMACY INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg .

Purpose

Urinary Analgesic

Warnings

Do not exceed recommended dosage

Ask doctor before use if you have

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

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

If pregnant or breast feeding,

Ask a health professional before use.

Keep out of reach of children

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

Use

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

Inactive ingredients

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

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

CVS MAXIMUM STRENGTH URINARY PAIN RELIEF phenazopyridine hydrochloride tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-713 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MAGNESIUM SILICATE

Product Characteristics Color brown Score no score Shape OVAL Size 9mm Flavor Imprint Code p99 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69842-713-24 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-713-24) 2 NDC:69842-713-12 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-713-12)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/18/2019

Labeler — CVS PHARMACY INC (062312574)

Registrant — Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Operations
Reese Pharmaceutical Co		004172052	relabel (69842-713), repack (69842-713)

Revised: 09/2021 CVS PHARMACY INC