PHENAZOPYRIDINE HCL tablet, film coated

Phenazopyridine HCl by

Drug Labeling and Warnings

Phenazopyridine HCl by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine HCl 97.5 mg

PURPOSE

Purpose

Urinary Tract Analgesic

Use

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

WARNINGS

Do not exceed recommended dosage

Ask a doctor before use if you have

■ kidney disease

■ allergies to foods, preservatives or dyes

■ had a hypersensitive reaction to Phenazopyridine Hydrochloride

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

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Keep out of reach of children

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

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 for up to two days.

■ 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 and other items if handled after touching tablets

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

■ long term administration of phenazopyridine HCI 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 room temperature 15°-30°C (59°-86°F) in a dry place and protect from light

WARNING This product can expose you to Phenazopyridine Hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

INACTIVE INGREDIENT

carnauba wax, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide.

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

Caution: Tablets sealed in blister. Do not use if blister is opened or damaged

*This product is not manufactured or distributed by i-Health, Inc., distributor of AZO Urinary Pain Relief® Maximum Strength.

Distributed by: CVS Pharmacy, Inc. One CVS Drive,

Woonsocket, RI 02895 © 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-34571

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in AZO Urinary Pain Relief® Maximum Strength*

MAXIMUM STRENGTH

Urinary Pain Relief

PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg

Quickly eases urinary pain, burning & urgency

More active ingredient for maximum relief

Provides targeted relief for urinary pain

24 Tablets Individually Sealed

INGREDIENTS AND APPEARANCE

PHENAZOPYRIDINE HCL 
phenazopyridine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-538
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	97.5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	CZ
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-538-24	2 in 1 CARTON	06/22/2018	01/31/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/22/2018	01/31/2021

Labeler - CVS Pharmacy, Inc. (062312574)