URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
Strategic Sourcing Services LLC

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

  • urinary pain
  • burning
  • urgency
  • frequency associated with urinary tract infection

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

  • adults and children 12 years of age and over: take 2 tablets 3 times per day with or after meals as needed. Take with a full glass of water.
  • children under 12 years of age: consult a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if cellophane packet is torn or open
  • *This product is not manufactured or distributed by Amerifit Brands, Inc., the distributor of AZO Standard®.

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 DRUGItem Code (Source)NDC:49348-364
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 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
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code CPC64
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-364-441 in 1 CARTON07/09/201012/31/2019
130 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/09/201012/31/2019
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 9/2019
 
Strategic Sourcing Services LLC