Otc - Active Ingredient
PHENAZOPYRIDINE HYDROCHLORIDE 97.5 MG
Topcare Maximum Strength Urinary Pain Relief
FDA Label NDC 36800-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Maximum Strength Urinary Pain Relief (NDC 36800-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
URINARY ANALGESIC
Warnings
DO NOT EXCEED RECOMMENDED DOSAGE
Otc - Ask Doctor
ASK DOCTOR BEFORE USE
IF YOU HAVE KIDNEY DISEASE
ALLERGIES TO FOODS,PRESERVATIVES OR DYES
HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE
Otc - 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.
Otc - 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
Otc - Pregnancy Or Breast Feeding
ASK A HEALTH PROFESSIONAL BEFORE USE
Otc - 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.
Package Label.Principal Display Panel
Image Of Carton (Topcaremax0001)
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.
* Please review the disclaimer below.
