LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

Leader Maximum Strength Urinary Pain Relief by

Drug Labeling and Warnings

Leader Maximum Strength Urinary Pain Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Reese Pharmaceutical Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0523
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	99.5 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0523-1	1 in 1 CARTON	10/10/2019
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		10/10/2019

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(70000-0523) , repack(70000-0523)