CVS HEALTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
Reese Pharmaceutical Co

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 95 mg

Purpose

Urinary Analgesic

Uses

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

Warning

Do not exceed recommended dosage

Ask Doctor before use if you have


■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine

When using this product

■ 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 the 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

Inactive Ingredients

lactose, magnesium silicate, magnesium stearate, microcrystalline

cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,

croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.

image of carton
CVS HEALTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-001
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code P95
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10956-001-301 in 1 CARTON07/27/2016
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2013
Labeler - Reese Pharmaceutical Co (004172052)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(10956-001) , repack(10956-001)

Revised: 2/2019
Document Id: e713b453-9a16-4ca5-add9-d3b40716c554
Set id: 0f0a19cd-0c6d-43f9-a6d5-183fb5fa4fe5
Version: 2
Effective Time: 20190206
 
Reese Pharmaceutical Co