LEADER AZO TABS URINARY TRACT ANALGESIC - 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

Phenazopyridine Hydrochloride 95 mg

Purpose;


Urinary Analgesic

Uses

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

urinary tract infections.

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.

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

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.

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.

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.

image of carton
LEADER AZO TABS URINARY TRACT ANALGESIC 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code CPC64;A5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-308-011 in 1 CARTON
1NDC:37205-308-6432 in 1 CELLO PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/05/2004
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel, repack

Revised: 1/2011
Document Id: cdb94bdc-f01d-4cea-b07b-ad180c559ae2
Set id: 9ab3c775-3f37-4236-81dc-fb432915ee53
Version: 1
Effective Time: 20110103
 
Cardinal Health