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UTI-Pain

Dosage form: tablet
Ingredients: PHENAZOPYRIDINE HYDROCHLORIDE 95mg
Labeler: Method Pharmaceuticals
NDC Code: 58657-510

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.

UTI-Pain Tablets

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 doctor if

  • symptoms persist 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

Carnauba Wax, Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch

Distributed by:

Method Pharmaceuticals, LLC.

Arlington, TX 76006

UTI-PAIN 
phenazopyridine hydrochloride 95 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-510
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
STARCH, PREGELATINIZED CORN 
Product Characteristics
Colorbrown (Reddish Brown) Scorescore with uneven pieces
ShapeROUNDSize7mm
FlavorImprint CodeM510
Contains    
Packaging
#Item CodePackage Description
1NDC:58657-510-3030 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/10/2014
Labeler - Method Pharmaceuticals (060216698)

Revised: 12/2015
 
Method Pharmaceuticals

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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