Urinary Pain Relief Phenazopyridine Hydrochloride PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A S159
Drug Facts
Composition & Profile
Identifiers & Packaging
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 PRINCIPAL DISPLAY PANEL - 95 mg Tablet Blister Pack Carton
- 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 PRINCIPAL DISPLAY PANEL - 95 mg Tablet Blister Pack Carton
Overview
Uses Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions
Indications & Usage
Uses Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions
Dosage & Administration
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
Warnings & Precautions
Warnings Do not exceed recommended dosage 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. 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. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Purpose
Purpose Urinary tract analgesic
Do Not Use
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
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 & Ask a Doctor
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.
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.
Storage & Handling
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.
Questions
Questions or comments? call 1-800-632-6900
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