{"adverse_reactions":["T he following adverse events have been reported: CNS: headache. Gastro intestinal: nausea, vomiting and diarrhea. Dermatologic and Hypersensitivity: rash, pruritus, disco lo ratio n, anaphylactoid-like reaction and hypersensitivity hepatitis. Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6 -PD deficiency, sulfhemoglobinemia. Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, disco lo ratio n o f body fluids and aseptic meningitis."],"boxed_warning":["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."],"clinical_pharmacology":["Phenazopyridine hydro chloride is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning , urgency and frequency. The precise mechanism of action is unknown."],"contraindications":["In patients who are hypersensitive to the drug o r its ingredients. Phenazopyridine is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis o r pyelonephritis o f pregnancy. It should be used cautiously in the presence o f GI disturbances."],"description":["Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula: Phenazopyridine HCI oral tablets contain the following inactive ingredients: pregelatanized starch, corn starch, silicon dioxide, micro crystalline cellulose , croscarmellose sodium, magnesium stearate and PVPK30 formula"],"dosage_and_administration":["100 mg Tablets: Average adult do sag e is two tablets 3 times a day after meals. 200 mg Tablets: Average adult do sag e is o ne tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration o f Phenazopyridine Hydrochloride should no t exceed 2 days."],"effective_time":"20180315","how_supplied":["Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP. Store at 20 ° to 25° C (6 8 ° to 77° F) [See USP Controlled Ro o m Temperature]. Dis tribute d in 1 bottle o f 10 0 tablets. NDC 6 9 36 7- 16 2-0 4 10 0 mg , 10 0 count - Appearance : Reddish-brown, round, film coated tablets NDC 6 9 36 7- 16 3 -0 4 20 0 mg , 10 0 count - Appearance : Reddish-brown, round, film coated tablets KEEP THIS AND ALL MEDICAT ION OUT OF T HE REACH OF CHILDREN. Manufactured for: Sola Pharmaceuticals , LLC 18169 E. Petroleum Dr. Suite B Baton Rouge, LA, 70809 Rev: 0 2 /18"],"id":"677fbdd8-4cf8-10c8-e053-2991aa0a7312","indications_and_usage":["Phenazopyridine HCL is indicated for the symptomatic relief o f pain, burning , urgency frequency, and other discomforts arising fro m irritation o f the mucosa o f the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures , o r the passage e o f sounds, o r catheters. T he use o f Phenazopyridine for relief o f symptoms should no t delay definitive diagnosis and treatment o f causative conditions. T he drug should be used for symptomatic relief o f pain and no t as a substitute fo r specific surgery o r antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection . Treatment o f a urinary tract infection with Phenazopyridine should no t exceed 2 days. T here is no evidence that the combined administration o f Phenazopyridine and an antimicrobial provides greater benefit than administration o f the antimicrobial alone after 2 days. (See Do sag e and Administration.)"],"openfda":{},"package_label_principal_display_panel":["NDC 70512-003-10 Phenazopyridine Hydrochloride , USP 200 mg Rx only 100 Tablets NDC 70512-002-10 Phenazopyridine Hydrochloride , USP 100 mg Rx only 100 Tablets label200 label"],"pharmacokinetics":["The pharmacokinetic properties of Phenazopyridine hydrochloride have not been determined. Phenazopyridine and its metabolites are rapidly excreted by the kidneys. In a small number o f healthy subjects, 9 0 % o f a 6 0 0 mg /day oral dose of Phenazopyridine hydrochloride was eliminated in the urine in 24 hours, 4 1% as unchanged drug and 4 9 % as metabolites."],"set_id":"66208fa4-822d-5d19-e053-2991aa0a3cb8","spl_product_data_elements":["Phenazopyridine Phenazopyridine PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE POVIDONE K30 STARCH, PREGELATINIZED CORN SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM CROSCARMELLOSE MAGNESIUM STEARATE 2 Phenazopyridine Phenazopyridine PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE POVIDONE K30 STARCH, PREGELATINIZED CORN SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM CROSCARMELLOSE MAGNESIUM STEARATE 2"],"version":"2","warnings_and_cautions":["Phenazopyridine hydrochloride is reasonably anticipated to be a human carcinog en based o n sufficient evidence o f carcinogenicity in experimental animals (IARC 19 8 0 , 19 8 2, 19 8 7, NCI 19 78 ). When administered in the diet, Phenazopyridine hydrochloride increased the incidences o f hepatocellular adenomas and carcinomas in female mice and adenomas and adenocarcinomas o f the co lo n and rectum in rats o f both sexes. T here is inadequate evidence for the carcinogenicity o f Phenazopyridine hydrochloride in humans (T ARC 19 8 7). In o ne limited epidemiological study, no significant excess o f any cancer was observed among 2,214 patients who received Phenazopyridine hydrochloride and were followed for a minimum o f 3 years. PRECAUT IONS General: T he patient should be advised that Phenazopyridine produces an o rang e to red co lo r in the urine and feces, and may cause staining . Phenazopyridine may cause disco lo ratio n o f body fluids and staining o f contact lenses has been reported. A yellowish co lo r o f the skin o r sclera may indicate accumulation o f Phenazopyridine resulting fro m impaired renal function and necessitates discontinuance o f the drug . It should be no ted that a decline in renal function is common in elderly patients. Phenazopyridine may mask pathological conditions and interfere with laboratory test values using colorimetric, spectrophotometric o r fluorometric analysis methods. Cautious use in patients with G-6 -PD deficiency is advised since these patients are susceptible to oxidative hemolysis and may have greater potential to develop hemolytic anemia. Information for Patients : T he patient should be advised to take Phenazopyridine with o r following foo d o r after eating a snack to reduce stomach upset. T he patients should be aware that Phenazopyridine causes a reddish o rang e disco lo ratio n o f the urine and feces, and may stain clothing . Phenazopyridine may cause disco lo ratio n o f body fluids and staining o f contact lenses has been reported. T here have been reports o f teeth disco lo ratio n when the pro duct has been bro ken o r held in the mouth prior to swallowing . Patients should be instructed to take Phenazopyridine for only 2 days if an antibacterial agent is administered concurrently for the treatment o f a urinary tract infection. If symptoms persist beyond those 2 days, the patient should be instructed to contact his o r her physician. Laboratory Tests : Phenazopyridine may interfere with laboratory test values using colorimetric, pho to metric o r fluorometric analysis methods. Altered urine laboratory test values may include ketone (sodium nitroprusside) , bilirubin (foam test, talc-disk-Fouchet-spot test, Franklin 's tablet-Fouchet test, p-nitro benzene diazonium p-toluene sulfonate reag ent), diacetic acid (Gerhardt ferric chloride test), free hydrochloric acid, glucose (glucose oxidase tests), 17-hydroxycorticosteroids (modified Glenn-Nelson), 17-keto steroids (Holtorff Koch modification o f Zimmerman), porphyrins, albumin (disco lo rs bro mophenol blue test areas o f commercial reagent strips, nitric acid ring test), phenolsulfophthalein , urobilinogen (co lo r interference with Ehrlich 's reagent), and urinalysis (spectrophotometric o r co lo r-based tests). Phenazopyridine also imparts an o rang e-red co lo r to stools which may interfere with co lo r tests. Drug Interactions : T he interaction o f Phenazopyridine with other drug s has no t been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported. Carcinogenesis , Mutagenesis , Impairment o f Fertility: Long -term administration o f Phenazopyridine has been associated with tumors o f the large intestine in rats and o f the liver in mice. Available epidemiological data are insufficient to evaluate the carcinogenicity o f Phenazopyridine in humans. In vitro studies indicate that Phenazopyridine in the presence o f metabolic activation is mutagenic in bacteria and mutagenic and clastogenic in mammalian cells. Pregnancy Cate gory B: Reproductive studies with Phenazopyridine (in combination with sulfacytine) in rats given up to 110 mg /kg /day and in rabbits given up to 39 mg /kg /day during organogenesis revealed no evidence o f harm to offspring. One prospective study in human s demonstrated that Phenazopyridine traverses the placenta into the fetal compartment. T here are no adequate and well-controlled studies in pregnant women. Therefore, Phenazopyridine should be used in pregnant women only if the benefit clearly outweighs the risk. Nursing Mothers : It is no t known whether Phenazopyridine o r its metabolites arc excreted in human milk. Because many drug s are excreted in human milk, a decision should be made to discontinue nursing o r to discontinue the drug , taking into account the importance o f drug therapy to the mother. Children: Adequate and well-controlled studies have no t been performed in the pediatric population. No pediatric-specific problems have been documented."]}