AZO - phenazopyridine hydrochloride tablet 
i-Health, Inc.

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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AZO Urinary Pain Relief Maximum Strength

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 mg

Purpose

Urinary analgesic

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

Warnings:

Please read insert for important precautions.

Ask a doctor before use if you have

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

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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 and ask doctor if

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

If pregnant or breastfeeding, ask a professional before use.

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

Directions

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

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
  • Store at room temperature (59-86 F) in a dry place and protect from light
  • Tamper evident: tablets sealed in blisters.  Do not use if blister foil or seal is open or damaged.

Inactive ingredients microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate.  May also contain corn starch.

Distributed by i-Health, Inc. 55 Sebethe Drive, Cromwell, CT 06416

Made in India.

¤»Neilsen data through January 26, 2013.

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

Fast Effective Pain Relief

AZO

Urinary Pain Relief

MAXIMUM STRENGTH

  • MORE ACTIVE INGREDIENT RELIEVES PAIN, BURNING & URGENCY
  • TARGETS THE SOURCE OF PAIN

#1 MOST TRUSTED BRAND

Tablets

97.5 mg Phenazopyridine Hydrochloride

PhenazoHCl12

PhenazoHCl24

AZO 
urinary pain relief tablet
Product Information
Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49973-244
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenazopyridine Hydrochloride (Phenazopyridine ) Phenazopyridine Hydrochloride 97.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
HYPROMELLOSES  
POVIDONE  
CROSCARMELLOSE SODIUM  
POLYETHYLENE GLYCOLS  
CARNAUBA WAX  
MAGNESIUM STEARATE  
Product Characteristics
Color brown Score no score
Shape OVAL (Tablet) Size 8mm
Flavor Imprint Code WX
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49973-244-12 6 in 1 BOX
1 2 in 1 BLISTER PACK
2 NDC:49973-244-24 12 in 1 BOX
2 2 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/18/2012
Labeler - i-Health, Inc. (061427694)
Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals, LLC 968119730 manufacture(49973-244)

Revised: 2/2014
i-Health, Inc.