SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH- phenazopyridine hydrochloride tablet

Sunmark Urinary Pain Relief Maximum Strength by

Drug Labeling and Warnings

Sunmark Urinary Pain Relief Maximum Strength by is a Otc medication manufactured, distributed, or labeled by McKesson, Reese Pharmaceutical Co, Pharbest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

PURPOSE

PHENAZOPYRIDINE HYDROCHLORIDE                     URINARY ANALGESIC

WARNINGS

DO NOT EXCEED RECOMMENDED DOSAGE

ASK DOCTOR

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

WHEN USING

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

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

PREGNANCY OR BREAST FEEDING

ASK A HEALTH PROFESSIONAL BEFORE US

KEEP OUT OF REACH OF CHILDREN

IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

DOSAGE & ADMINISTRATION

Adults and Children 12 years of age and over; take 2 tablets 3 times daily with a full glass of water,with or after meals as needed.

Children under 12 years of age; consult a doctor.

Do not use for more than 2 days ( 12 tablets ) without consulting a Doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH  
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-941
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	97.5 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	975
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-941-01	1 in 1 CARTON	11/18/2010
1	NDC: 49348-941-02	12 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		11/18/2010

Labeler - McKesson (177667227)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(49348-941) , repack(49348-941)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest		557054835	manufacture(49348-941)