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Azo Gesic

Generic Name: phenazopyridine hydrochloride
Dosage Form: tablet

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.

AZO Urinary Tract Health

Active Ingredient

Active Ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Purpose

Urinary analgesic

Indications

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Warnings

Warnings

DO NOT EXCEED RECOMMENDED DOSAGE

Ask Doctor

Ask a doctor before use if you have

  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine Hydrochloride

When Using

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

Stop use and ask doctor if

  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication.

Pregnancy

If pregnant or breastfeeding, ask a health professional before use. 

Keep Out of Reach of Children

Keep out of reach of children.  In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions

  • Adults: Take 2 tablets 3 times daily with or after meals as needed for up to two days.  Take with a full glass of water.  Do not use for more than 2 days (12 tablets) without consulting a doctor.
  • Children under 12: Do not use without consulting a doctor.
  • See enclosed insert for more information

Other Information

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
  • Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
  • Store at room temperature 15º - 30ºC (59º-86º F) in a dry place and protect from light.

Tamper evident: Product is dealed in cellophane.  Do not use if cellophane is open or damaged.

Questions?

  • To report adverse drug event call: (800) 616-2471

Inactive Ingredients

Inactive ingredients  Lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze and sodium starch glycolate.

Principal Display Panel

AZO-GESIC

Urinary Pain Relief   

  • For Prompt, Temporary Relief of Minor Pain, Burning and Discomfort of Urination

30 ​​Tablets

95 mg Phenazopyridine Hydrochloride

Azo Gesic 
phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0904-5025
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SHELLAC  
SODIUM STARCH GLYCOLATE TYPE A CORN  
Product Characteristics
Color BROWN (Maroon) Score no score
Shape ROUND (Tablet) Size 7mm
Flavor Imprint Code CPC64
Contains         
Packaging
# Item Code Package Description
1 NDC:0904-5025-46 15 BLISTER PACK in 1 BOX
1 2 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/25/2011
Labeler - Major Pharmaceuticals (191427277)
Revised: 10/2014
 
Major Pharmaceuticals



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