Your browser does not support JavaScript! URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON (SUNMARK)]
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RxNorm Names

URINARY PAIN RELIEF (phenazopyridine hydrochloride) tablet
[Mckesson (Sunmark)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE: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 Label Sections

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Another quality product Distributed by McKesson

One post street, San Franciso, CA 94104 

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Please visit us at www.sunmarkbrand.com

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
 
Mckesson (Sunmark)

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