FDA Label for Urinary Pain Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 95 MG TABLET BLISTER PACK CARTON
Urinary Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary tract analgesic
Uses
Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions
Warnings
Do not exceed recommended dosage
Otc - Do Not Use
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Ask A 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.
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
- long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 12 years and over: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor
- Children under 12 years: Do not use without consulting a doctor
Other Information
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain contact lenses and other items if handled after touching tablets.
- Store at room temperature between 15°C -30°C (59°F -86°F) in a dry place and protect from light.
Inactive Ingredients
colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate
Questions Or Comments?
call 1-800-632-6900
Principal Display Panel - 95 Mg Tablet Blister Pack Carton
*Compare to active ingredient of AZO® URINARY
PAIN RELIEF MAXIMUM STRENGTH *see back panel
NDC XXXXX-XXX-XX
Urinary
Pain Relief
Phenazopyridine
Hydrochloride 95 mg
FAST RELIEF
FOR URINARY
DISCONFORT
actual
size
30 TABLETS
* Please review the disclaimer below.