URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
Mckesson (Sunmark)

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

for temporary relief of

Warnings

Do not use

for more than 2 days without consulting a doctor.

Ask a doctor before use if you have

  • kidney disease
  • hepatic or renal problems
  • allergies to foods, preservatives, or dyes
  • previously exhibited hypersensitivity to Phenazopyridine.

Stop use and ask a doctor if

  • symptoms persists for more than 2 days
  • yellowish tinge of skin or sclera occurs

When using this product

  • stomach upset may occur
  • a harmless reddish- orange color will be produced in the urine and may stain fabric
  • staining of the contact lenses may also occur

If pregnant or breast- feeding

Ask a health care 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

Other information

Inactive ingredients

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

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Compare to AZO STANDARD® active ingredient*

Urinary Pain Relief

Phenazopyridine HCl

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Sunmark urinary pain relief

Phenazopyridine Hydrochloride 95 mg

URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-364(NDC:10267-0064)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE95 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 Code CPC64
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-364-441 in 1 CARTON
130 in 1 CELLO PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 10/2012
Document Id: 18a65eb2-f8ff-48ea-b3c0-3b74fe81832c
Set id: b73f9b1f-aa6f-468f-880e-a7fa4bcf930b
Version: 1
Effective Time: 20121003
 
Mckesson (Sunmark)