Phenazopyridine Hydrochloride
Product Images NDC 70795-1252

Phenazopyridine is a film-coated tablet manufactured by Graxcell Pharmaceuticals LLC. The drug has not been approved by FDA due to lack of evidence regarding its safety and effectiveness. It contains Phenazopyridine Hydrochloride that is a red to violet-colored crystalline powder with local analgesic properties that provides relief to pain and burning in the urinary tract. This drug is only available with a prescription, and its detailed information can be found on the FDA website.*

Phenazopyridine HCl Tablets, USP is a medication primarily used for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts resulting from lower urinary tract mucosa irritation. It is compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Phenazopyridine HCI is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCI should be discontinued when symptoms are controlled.*

Phenazopyridine HCI should not be used in patients with a history of hypersensitivity to it or those with renal insufficiency. Adverse reactions include headache, rash, pruritus, and occasional gastrointestinal disturbances. The drug may cause methemoglobinemia, hemolytic anemia, renal, and hepatic toxicity at overdosage levels. A yellowish tinge of the skin or sclera may indicate the need to discontinue therapy. Phenazopyridine HCI causes urine to develop a reddish-orange discoloration and may stain fabric. It may interfere with urinalysis, and long-term administration has induced neoplasia in rats and mice. No epidemiological studies have been conducted to determine any association between Phenazopyridine HCI and human neoplasia.*

Phenazopyridine HCI is a pregnancy category B drug that has not been proven harmful to the fetus. It is recommended to be used during pregnancy only when clearly necessary. No information is available on the drug's effects on nursing mothers. The dosage and administration vary based on the strength of the tablets, with the recommended maximum dose being two days. Overdosing may cause toxic reactions, oxidative Heinz body hemolytic anemia, renal and hepatic impairment or occasionally hypersensitivity that may lead to failure.*

These are tablets supplied in bottles of 100 counts. There are two variants; one contains 100mg, while the other contains 200mg of the substance. The tablets are deep brown to maroon in color and are round, film-coated, and debossed with "G-15" or "G-17." They have a child-resistant closure and must be stored in a tight container at temperatures between 15°C to 30°C. These tablets are manufactured by Graxcell Pharmaceuticals LLC in Bohemia, New York.*

This is a medication label for Phenazopyridine Hydrochloride. Each tablet contains 200mg and there are 40 tablets in a bottle. It is a prescription drug and manufactured by L ARCETOLLE. The rest of the text is not legible.*