Phenazopyridine Hydrochloride
Product Images NDC 70795-1241

This is the information of a pharmaceutical product called Phenazopyridine Hydrochloride Oral Tablet, USP with strength of 100mg supplied by GRAICELL PHARMACEUTICAL LLC and GRAXCELL PHARMACEUTICAL LLC. Each tablet contains Phenazopyridine HCL. USH. The Product has an NDC code of 7070512410. It is for oral use and available in bottle containing 409 Tablets.*

Phenazopyridine is a film-coated tablet manufactured by Graxcell Pharmaceuticals LLC. However, the drug is not approved by the FDA, and caution is advised when taking it as federal law prohibits its dispensing without prescription. Phenazopyridine Hydrochloride is the active ingredient of this drug, which promptly eases burning and pain in the urinary tract. It appears as a light or dark red to dark violet, odorless, slightly bitter crystalline powder. The molecular weight of this powder is 249.70, and it has a specific local analgesic effect in the urinary tract.*

Phenazopyridine HCI Tablets, USP is a medication used for symptomatic relief of urinary tract mucosa irritations such as pain, burning, urgency, and frequency caused by different conditions. It contains inactive ingredients such as croscarmellose sodium, colloidal silicon dioxide, and hydroxypropyl methylcellulose. Phenazopyridine HCI exerts a topical analgesic effect on the urinary tract's mucosa while being rapidly excreted by the kidneys. Although it could reduce or eliminate the need for systemic analgesics, its use should not delay treatment of causative conditions. The combined use of Phenazopyridine HCI and an antibacterial for the treatment of urinary tract infections should not exceed two days.*

Phenazopyridine HCI is a medication that should not be used in patients with a history of hypersensitivity or renal insufficiency. Adverse reactions may include headache, rash, pruritus, gastrointestinal disturbance or anaphylactoid-like reactions. Over dosages can lead to Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity. Impaired renal excretion may indicate accumulation, which requires the discontinuation of therapy. Phenazopyridine HCI may produce reddish-orange urine coloration and may stain fabrics and contact lenses. Long-term use has induced neoplasia in rats and mice. There are no adequate epidemiological studies on the association between Phenazopyridine HCI and human neoplasia.*

Phenazopyridine HCI is classified as Pregnancy Category B and has been tested for reproduction studies in rats with no evidence of impaired fertility. However, there are no adequate studies in pregnant women, and caution should be exercised when using during pregnancy. No information is available on the appearance of Phenazopyridine HCI or its metabolites in human milk. The recommended dosage for adults ranges from 100 mg to 200 mg tablets, taken up to 3 times a day after meals. Phenazopyridine HCI should not be administered for more than 2 days when used with an antibacterial agent for the treatment of a urinary tract infection. Overdose may result in increased serum levels, toxic reactions, oxidative Heinz body hemolytic anemia, and renal/hepatic impairment or failure.*

This medication is available in two strengths of tablets: 100mg and 200mg. The 100mg tablets come in bottles of 100 counts with NDC code 70795-1241-0 and are deep brown to maroon in color, round, film coated, with "G-15" debossed on one side and plain on the other. The 200mg tablets come in bottles of 100 counts with NDC code 70795-1252-0 and are also deep brown to maroon in color, round, film coated, with "G-17" debossed on one side and plain on the other. The medication should be dispensed with child-resistant closure and stored at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) as defined in the USP. This medication is manufactured for Graxcell Pharmaceuticals LLC based in Bohemia, NY.*