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Phenazopyridine hydrochloride 95mg

Dosage form: tablet
Ingredients: PHENAZOPYRIDINE HYDROCHLORIDE 95mg
Labeler: AMOL PHARMACEUTICALS PRIVATE LIMITED
NDC Code: 63189-001

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Phenazopyridine hydrochloride Tablets 95mg

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary tract 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 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 health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

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

Directions • Adults and children 12 years and 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. Do not use for more than 2 days (12 tablets) without consulting a doctor • Children under 12: Do not use without consulting doctor.

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

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: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

Urinary Tract Health

SUPPORT PACK

• RELIEVES PAIN, BURNING AND URGENCY

• TARGETS THE SOURCE OF PAIN

MOST TRUSTED #1 BRAND

AZO Urinary Pain Relief® is made in India.

Most Trusted Brand based on Nielsen data through 12/27/14 and the 2014 Pharmacy Times OTC Survey.

Contains the #1 doctor recommended ingredient to help relieve urinary pain and discomfort

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

Size and color of tablets may vary.

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

www.azoproducts.com

AZO Urinary Pain Relief® used under license by i-Health, Inc.

Packaging

Packaging

PHENAZOPYRIDINE HYDROCHLORIDE 95MG 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63189-001
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 
HYPROMELLOSE, UNSPECIFIED 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
MAGNESIUM STEARATE 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeW
Contains    
Packaging
#Item CodePackage Description
1NDC:63189-001-301 BLISTER PACK in 1 CARTON
130 TABLET in 1 BLISTER PACK
2NDC:63189-001-181 BLISTER PACK in 1 BOX
218 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/2015
Labeler - AMOL PHARMACEUTICALS PRIVATE LIMITED (676245969)
Establishment
NameAddressID/FEIOperations
AMOL PHARMACEUTICALS PRIVATE LIMITED676245969manufacture(63189-001)

Revised: 11/2017
 
AMOL PHARMACEUTICALS PRIVATE LIMITED