Label: SULFASALAZINE tablet
- NDC Code(s): 50090-0086-0, 50090-0086-3, 50090-0086-4
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 59762-5000
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated April 8, 2025
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- Official Label (Printer Friendly)
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DESCRIPTIONSulfasalazine tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo ...
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CLINICAL PHARMACOLOGYPharmacodynamics - The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or ...
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INDICATIONS AND USAGESulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - b) for the prolongation of the ...
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CONTRAINDICATIONSSulfasalazine tablets are contraindicated in: Patients with intestinal or urinary obstruction, Patients with porphyria as sulfonamides have been reported to precipitate an acute ...
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WARNINGSHepatic, Renal, and Hematologic Toxicity or Other Conditions - Only after critical appraisal should Sulfasalazine tablets be given to patients with hepatic or renal damage or blood dyscrasias ...
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PRECAUTIONSGeneral: Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and ...
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ADVERSE REACTIONSThe most common adverse reactions associated with sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third ...
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DRUG ABUSE AND DEPENDENCENone reported.
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OVERDOSAGEThere is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea ...
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DOSAGE AND ADMINISTRATIONThe dosage of sulfasalazine tablets should be adjusted to each individual's response and tolerance. Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not ...
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HOW SUPPLIEDProduct: 50090-0086 - NDC: 50090-0086-4 90 TABLET in a BOTTLE
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REFERENCES1. Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981; 80:72–6. 2. Kaufman DW, editor. Birth defects ...
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SPL UNCLASSIFIED SECTIONLAB-0243-18.0 - Revised: 02/2025
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Sulfasalazine
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INGREDIENTS AND APPEARANCEProduct Information