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Preferred Urinary Pain Relief by Unit Dose Services

Dosage form: tablet
Ingredients: PHENAZOPYRIDINE HYDROCHLORIDE 95mg
Labeler: Unit Dose Services
NDC Code: 50436-0551

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.

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.

HOW SUPPLIED

Product: 50436-0551

NDC: 50436-0551-1 30 TABLET in a BOTTLE

PREFERRED URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET
PREFERRED URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-0551(NDC:10956-551)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SHELLAC 
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM SILICATE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeP95
Contains    
Packaging
#Item CodePackage Description
1NDC:50436-0551-1 30 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2013
Labeler - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-0551), RELABEL(50436-0551)

 
Unit Dose Services

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Medically reviewed on May 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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