DRUG FACTS

DRUG FACTS

Drug Labeling and Warnings

Drug Details

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DOLLAR GENERAL MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
Dolgencorp, Inc.

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 (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg .

Purpose

Urinary Analgesic

Warnings

Do not exceed recommended dosage

Ask doctor before use if you have

■ kidney disease
■ allergies to food, 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 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 reach of children

In case of an overdose, get medical help or contact a Poison Control Center right away.

Use

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

Inactive ingredients

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

Directions


■ adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor

image of carton

DOLLAR GENERAL MAXIMUM STRENGTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55910-631
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
Product Characteristics
ColorbrownScoreno score
ShapeOVALSize9mm
FlavorImprint Code p99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55910-631-121 in 1 CARTON10/03/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/03/2019
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(55910-631) , repack(55910-631)

Revised: 10/2019
 
Dolgencorp, Inc.


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