MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

Maximum Strength Urinary Pain Relief by

Drug Labeling and Warnings

Maximum Strength Urinary Pain Relief by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, INVAHEALTH INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg 

Purpose

Urinary tract analgesic

Use

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

Warnings

Do not exceed recommended dosage.

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 useif 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 a doctor if

your symptoms last for more than 2 days 

you suspect you are having an adverse reaction to the medication.

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.

If pregnant or breastfeeding, ask a 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 a Poison Control Center right away.

Other information

This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

This product may stain contact lenses and other items if handled after touching tablets.

Store at room temperature between (59ºF -86ºF) in a dry place and protect from light.

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 years:Do not use without consulting a doctor

Inactive ingredients

pregelatinized starch, microcrystalline cellulose, maize (corn) strach, povidone, croscarmellose sodium, magnesium stearate, colloidal silicone dioxide, hydroxypropyl methylcellulose, polyethylene glycol.

Questions?

call toll-free 1-800-630-8895

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in  AZO Urinary Pain Relief ®Maximum Strength*  

NDC: 80513-517-72

Maximum Strength Urinary Pain Relief

99.5 mg Phenazopyridine Hydrochloride

#1 DOCTOR RECOMMENDED OTC INGREDIENT FOR UTI PAIN

TEMPORARY RELIEF OF URINARY PAIN, BURNING & URGENCY

Urinary Analgesic

72 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Size and color of tablet may very.

WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

*This product is not manufactured or distributed by I-Health, Inc., owner of the registered trademark of AZO Urinary Pain Relief ®Maximum Strength

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN USA

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-517
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	99.5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	SP9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-517-72	72 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2024

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
INVAHEALTH INC.		116840615	manufacture(80513-517)