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 TARGET CORPORATION. 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. Treatment should not exceed 2 days; see Directions

Warnings

Do not exceed recommended dosage

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

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 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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl 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.

Directions

Adults and children 12 years and over: 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

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 20ºC -25ºC (68ºF-77ºF) in a dry place and protect from light.

Inactive ingredients

colloidal silicon dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.

Questions or comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

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

Provides relief from urinary pain and burning
Maximum strength UTI pain reliever available without a prescription†

†Among our over-the-counter urinary pain relief products

245 03 0248 ROO C-002445-01-009-0000
Distributed by Target Corporation
Minneapolis, MN 55403
Made in India
TM & ©2024 Target Brands, Inc.

*This product is not manufactured or distributed by i-Health Inc., distributor of AZO® Urinary Pain Relief

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more information, visit www.p65warnings.ca.gov

Packaging

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-270
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACACIA (UNII: 5C5403N26O)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	brown (Dark Brown)	Score	no score
Shape	RECTANGLE	Size	9mm
Flavor		Imprint Code	S160
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-270-24	1 in 1 CARTON	01/25/2023
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/25/2023

Labeler - TARGET CORPORATION (006961700)