MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
KROGER COMPANY

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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Maximum Strength Urinary Pain Relief

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

Purpose

Urinary tract analgesic

Uses

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Warnings

Do not exceed recommended dosage

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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

  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication
  • long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

If pregnant or breastfeeding, ask a health professional before use.A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

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

Directions

Other information

Inactive ingredients

colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate

Questions or comments?

call 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 99.5 mg Tablet Blister Pack Carton

COMPARE TO the active ingredient of AZO® URINARY
PAIN RELIEF® MAXIMUM STRENGTH *See back panel

NDC 30142-756-24

Kroger®

OUR PHARMACIST RECOMMENDED

Maximum Strength

Urinary
Pain Relief

Phenazopyridine
Hydrochloride 99.5 mg

FAST RELIEF FOR
URINARY PAIN,
BURNING &
URGENCY

Strongest UTI
Pain Reliever
Available Without
a Prescription

Even Higher Dose
for Maximum Relief

Targets the Source of Pain

actual
size

Among our urinary
pain relief products

24 TABLETS

PRINCIPAL DISPLAY PANEL - 99.5 mg Tablet Blister Pack Carton
MAXIMUM STRENGTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-756
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
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Lactose Monohydrate (UNII: EWQ57Q8I5X)  
Magnesium Stearate (UNII: 70097M6I30)  
Starch, Corn (UNII: O8232NY3SJ)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Povidone, Unspecified (UNII: FZ989GH94E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Starch Glycolate Type A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorBROWNScoreno score
ShapeOVALSize10mm
FlavorImprint Code S160
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-756-241 in 1 CARTON05/01/2021
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/01/2021
Labeler - KROGER COMPANY (006999528)

Revised: 12/2023
Document Id: a4a5f566-eb9e-46d1-b93e-f00d32b796ba
Set id: 3334e3f6-f57c-45f9-9fa5-5ea3f93d335a
Version: 3
Effective Time: 20231230
 
KROGER COMPANY