The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
DISTRIBUTED BY THE KROGER CO.CINCINNATI, OHIO 45202
Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 95 mg
Urinary tract analgesic
Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions
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 diseaseallergies 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 upsetyour 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 daysyou suspect you are having an adverse reaction to the medicationlong-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.
- 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 doctorChildren under 12 years: Do not use without consulting a doctor
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones testsThis 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.
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
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