TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet 
TOPCO ASSOCIATES LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DRUG FACTS

ACTIVE INGREDIENT

 PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

PURPOSE

URINARY ANALGESIC

WARNINGS

DO NOT EXCEED RECOMMENDED DOSAGE

ASK DOCTOR SECTION

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

WHEN USING SECTION

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 SECTION

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 USE

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.

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.

INACTIVE INGREDIENT

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

image of carton
TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 975
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-103-011 in 1 CARTON02/01/2011
1NDC:36800-103-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2011
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(36800-103) , repack(36800-103)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.057795122manufacture(36800-103)

Revised: 1/2019
Document Id: 68b67760-6330-46f4-83f8-835c1f9f787c
Set id: 2d3fcf6d-5965-425c-896b-a3b895e4fd44
Version: 2
Effective Time: 20190130
 
TOPCO ASSOCIATES LLC