Generic Name: phenazopyridine hydrochloride
Dosage Form: tablet
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.
AZO Urinary Tract Health
Active Ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
DO NOT EXCEED RECOMMENDED DOSAGE
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
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 doctor if
- your symptoms last for more than 2 days
- you suspect you are having an adverse reaction to the medication.
If pregnant or breastfeeding, ask a health professional before use.
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.
- Adults: 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: Do not use without consulting a doctor.
- See enclosed insert for more information
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
- Store at room temperature 15º - 30ºC (59º-86º F) in a dry place and protect from light.
Tamper evident: Product is dealed in cellophane. Do not use if cellophane is open or damaged.
- To report adverse drug event call: (800) 616-2471
ï»¿Inactive ingredients ï»¿Lactoseï»¿, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze and sodium starch glycolate.
Principal Display Panel
Urinary Pain Relief
- For Prompt, Temporary Relief of Minor Pain, Burning and Discomfort of Urination
95 mg Phenazopyridine Hydrochloride
phenazopyridine hydrochloride tablet
|Labeler - Major Pharmaceuticals (191427277)|
More about Azo-Gesic (phenazopyridine)
- Other brands: Pyridium