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Urinary Pain Relief by The Kroger Co

Medically reviewed on August 28, 2017

Dosage form: tablet
Ingredients: PHENAZOPYRIDINE 95mg
Labeler: The Kroger Co
NDC Code: 30142-640

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 (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary analgesic

Uses

provides temporary relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

Warnings

Ask a doctor before use if you have
  • kidney disease
  • allergies to foods, preservatives, or dyes
  • had a hypersensitive reaction to Phenazopyridine.

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

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 reach of children.

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

Directions
  • adults and children 12 years and older: take 2 tablets 3 times daily with or after meals as needed. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor
  • children under 12 years: do not use without consulting a doctor

Other information
  • this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • this product may stain soft contact lenses and other items if handled after touching tablets
  • store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light
  • do not use if cellophane packet is torn or open
  • *Azo standard® is a registered trademark of Amerifit Brands, Inc., Cromwell, CT 06416. Amerifit Brands, Inc. is not affiliated with the Kroger Co. or this product

Inactive ingredients

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

Questions or comments?

1-800-632-6900

Principal Display Panel

Kroger®

Compare to active ingredient of AZO STANDARD® urinary pain relief. *See back panel

SEE NEW WARNINGS INFORMATION

Urinary Pain Relief

Phenazopyridine HCl

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by The Kroger Co. Cincinnati, Ohio 45202

Urinary Pain Relief

URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-640
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE (PHENAZOPYRIDINE) PHENAZOPYRIDINE95 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeCPC64
Contains    
Packaging
#Item CodePackage Description
1NDC:30142-640-301 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
130 TABLET (30 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/11/2012
Labeler - The Kroger Co (006999528)

 
The Kroger Co

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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