LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
Cardinal Health

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.

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DRUG FACTS

ACTIVE INGREDIENT

PHENAZOPYRIDINE HYDROCHLORIDE 97.5 MG

PURPOSE

URINARY ANALGESIC

WARNINGS

DO NOT EXCEED RECOMMENDED DOSAGE

ASK DOCTOR

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

WHEN USING

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.

PREGNANCY OR BREAST FEEDING

ASK A HEALTH PROFESSIONAL BEFORE USE

KEEP OUT OF REACH OF CHILDREN

IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

DOSAGE & ADMINISTRATION

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.

Children under 12 years of age; consult a doctor.

Do not use for more than 2 days ( 12 tablets ) without consulting a Doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton

LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-630
Route of Administration	ORAL

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

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

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	975
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-630-01	1 in 1 CARTON	04/30/2009	08/23/2020
1	NDC:37205-630-53	12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/30/2009	08/23/2020

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Name	Address	ID/FEI	Business Operations
Establishment
Reese Pharmaceutical Co		004172052	relabel(37205-630) , repack(37205-630) , manufacture(37205-630)

Revised: 4/2020

Document Id: 9d1458e3-dae0-4876-a46c-0052df71d673

Set id: 032bb99c-0132-4859-af14-985fa3e598fc

Version: 4

Effective Time: 20200420

Cardinal Health