LEADER AZO TABS URINARY TRACT ANALGESIC- phenazopyridine hydrochloride tablet

LEADER Azo Tabs Urinary Tract Analgesic by

Drug Labeling and Warnings

LEADER Azo Tabs Urinary Tract Analgesic 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

Phenazopyridine Hydrochloride 95 mg

PURPOSE

Purpose;


Urinary Analgesic

INDICATIONS & USAGE

Uses

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

urinary tract infections.

WARNINGS

Do not exceed recommended dosage

ASK DOCTOR

Ask a 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.

STOP USE

Stop use and ask a doctor if

if your symptoms last for more than 2 days

you suspect you are having an adverse reaction

to the medication.

PREGNANCY OR BREAST FEEDING

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 an overdose,get medical help or contact

a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 and over; take 2 tablets 3 times daily with a

full glass of water,with or after meals as needed.

Children under 12 consult a doctor.

Do not use for more than 2 days ;12 tablets; without consulting a doctor.

INACTIVE INGREDIENT

magnesium stearate,microcrystalline cellulose.May also contain carnauba wax,

croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical

glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER AZO TABS URINARY TRACT ANALGESIC 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-308
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	95 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	CPC64;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-308-01	1 in 1 CARTON
1	NDC: 37205-308-64	32 in 1 CELLO PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/05/2004

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel, repack