RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC- phenazopyridine hydrochloride tablet

Rugby Phenazopyridine HCl Urinary Tract Analgesic by

Drug Labeling and Warnings

Rugby Phenazopyridine HCl Urinary Tract Analgesic by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Reese Pharmaceutical Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary Analgesic

Uses

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

Warning

Do not exceed recommended dosage

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

Ask Doctor before use if you have

■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine

When using this product

■ 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 breast feeding

ask a health professional before use.

Keep out of the reach of children

in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.

Directions

■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12 years: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Other Information

■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light

Inactive Ingredients

lactose, corn starch, croscarmellose sodium, microcrystalline

cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, 

pregelatinized starch, silicon dioxide, talc, and triacetin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1411
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	95 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	P95
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1411-07	1 in 1 CARTON	12/07/2023
1		30 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		12/07/2023

Labeler - Rugby Laboratories (079246066)

Registrant - Reese Pharmaceutical Co (004172052)