LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF

Dosage form: tablet
Ingredients: PHENAZOPYRIDINE HYDROCHLORIDE 97.5mg
Labeler: Cardinal Health
NDC Code: 37205-630

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.

DRUG FACTS


PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

URINARY ANALGESIC

DO NOT EXCEED RECOMMENDED DOSAGE

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

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.

ASK A HEALTH PROFESSIONAL BEFORE USE

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

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

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

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.

LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-630
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM SILICATE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code975
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-630-011 BLISTER PACK (BLISTER) in 1 CARTON
1NDC:37205-630-5312 TABLET (BLISTER) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/2009
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel, repack

Revised: 09/2011
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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