URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

Urinary Pain Relief by

Drug Labeling and Warnings

Urinary Pain Relief by is a Otc medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

PURPOSE

Purpose

Urinary Tract Analgesic

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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 a doctor if

■ your symptoms last for more than 2 days

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

■ Long-term adminitration of phenazopyridine hydrochloride has induced neoplasia in rats (large instestine) andmice (liver). Although no association between phenazopyridine hydrochloride and human enoplasia has beeen reported, adequate epidemiological studies along these lines have not been conducted.

If pregnant or breast-feeding, 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 (1-800-222-1222) right away.

OTHER SAFETY 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

■ long term administration of phenazopyridine HCI 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 15°-30°C (59°-86°F) in a dry place and protect from light

DOSAGE & ADMINISTRATION

■ Adults and children 12 years of age 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: Do not use wihout consulting a doctor

INACTIVE INGREDIENT

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

QUESTIONS

call toll-free 1-845-547-2667

SPL UNCLASSIFIED SECTION

Size and color of tablets may vary.

*This product is not manufactured or distributed by the owner of the registered trademark AZO Urinary Pain Relief®.

Distributed by: Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL

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

MAXIMUM STRENGTH

Urinary Pain Relief

PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg

Quickly eases urinary pain, burning & urgency

More active ingredient for maximum relief

Provides targeted relief for urinary pain

NDC: 71309-779-72 - 72 Count

NDC: 71309-779-28- 28Count

INGREDIENTS AND APPEARANCE

URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-779
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-779-72	72 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2022
2	NDC: 71309-779-28	28 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2022

Labeler - Safrel Pharmaceuticals, LLC. (080566287)