DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 97.5 mg
Urinary tract analgesic
INDICATIONS & USAGE
Use: Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Please read insert for important precautions.
Ask a doctor before use if you have
allergies to foods, preservatives or dyes
had a hypersensitive reaction to Phenazopyridine Hydrochloride.
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
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.
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breastfeeding, as a professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
DOSAGE & ADMINISTRATION
Adults and children 12 years or older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water.
Children under 12: Do not use without consulting a doctor
Do not use for more than 2 days (12 tablets) without consulting a doctor.
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
Store at room temperature (59-86 F) in a dry place and protect from light
Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
Carcinogenesis: Long-term administration of Phenazopyridine Hydrochloride 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.
Inactive ingredients microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. May also contain corn starch.
Distributed by i-Health, Inc. 55 Sebethe Drive, Cromwell, CT 06416
Made in India.
For questions, concerns, or to report an adverse event, call (800) 722-3476