URINARY PAIN RELIEF- phenazopyridine tablet 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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 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
  • *This product is not manufactured or distributed by Amerifit Brands, Inc., owner of the registered trademark Azo Standard®

Inactive ingredients

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

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to AZO Standard® active ingredient*

Urinary Pain Relief

Phenazopyridine HCl, 95 mg

For Relief of Urinary Pain

tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

www.goodneighborpharmacy.com

Package Label

 Phenazopyridine HCl 95 mg

Good Neighbor Pharmacy Urinary Pain Relief Tablet

URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE (UNII: K2J09EMJ52) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE95 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorRED (maroon) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code CPC64
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-013-651 in 1 CARTON
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 OTHER07/08/201008/09/2015
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)
Registrant - P & L Development, LLC (800014821)

Revised: 6/2013
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385