SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH - phenazopyridine hydrochloride tablet 
Bryant Ranch Prepack

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

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.

HOW SUPPLIED

NDC: 71335-1661-1: 6 Tablets in a BOTTLE

NDC: 71335-1661-2: 12 Tablets in a BOTTLE

NDC: 71335-1661-3: 36 Tablets in a BOTTLE

NDC: 71335-1661-4: 20 Tablets in a BOTTLE

NDC: 71335-1661-5: 10 Tablets in a BOTTLE

Phenazopyridine Hcl 97.5mg Tablet

Label
SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH  
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1661(NDC:49348-941)
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, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 975
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1661-16 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
2NDC:71335-1661-212 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
3NDC:71335-1661-336 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
4NDC:71335-1661-420 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
5NDC:71335-1661-510 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/18/2010
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1661) , RELABEL(71335-1661)

Revised: 12/2021
Document Id: 6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e
Set id: 6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e
Version: 2
Effective Time: 20211228
 
Bryant Ranch Prepack