UDSxMP Medicated System
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- UDSxMP Medicated System
- Generic name
- FUROSEMIDE, BENZALKONIUM CHLORIDE
- Manufacturer
- Wellbeing Medical Supply
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 06b901dc-0f1d-424f-8c4b-a29113cbab25
- SPL ID
- 620bb38c-3de2-46f3-8496-baa88a46666e
- Version
- 4
- Effective date
- 2025-06-12
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:37:32
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | UDSxMP Medicated System | openfda.brand_name | |
| generic name | FUROSEMIDE, BENZALKONIUM CHLORIDE | openfda.generic_name | |
| manufacturer name | Wellbeing Medical Supply | openfda.manufacturer_name | |
| ndc | package | 83315-200-01 | openfda.package_ndc |
| ndc | product | 83315-200 | openfda.product_ndc |
| ndc11 | package | 83315020001 | derived:openfda.package_ndc |
| rxcui | 1038558 | openfda.rxcui | |
| rxcui | 310429 | openfda.rxcui | |
| spl id | 620bb38c-3de2-46f3-8496-baa88a46666e | id | |
| spl set id | 06b901dc-0f1d-424f-8c4b-a29113cbab25 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs (see DOSAGE AND ADMINISTRATION ).
warnings
WARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) (see PRECAUTIONS: Drug Interactions ).
warnings
Warnings For external use only. For Professional and Hospital use only. Do not • use in the eyes • apply over large areas of the body. Consult a doctor in case of deep or puncture wounds, animal bites, or serious burns. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. hepatic encephalopathy in patients with hepatocellular insufficiency 6. oral and gastric irritation 7. cramping 2. pancreatitis 8. diarrhea 3. jaundice (intrahepatic cholestatic jaundice) 9. constipation 4. increased liver enzymes 10. nausea 5. anorexia 11. vomiting Systemic Hypersensitivity Reactions 1. severe anaphylactic or anaphylactoid reactions (e.g., with shock) 3. interstitial nephritis 2. systemic vasculitis 4. necrotizing angiitis Central Nervous System Reactions 1. tinnitus and hearing loss 5. headache 2. paresthesias 6. blurred vision 3. vertigo 7. xanthopsia 4. dizziness Hematologic Reactions 1. aplastic anemia 5. leukopenia 2. thrombocytopenia 6. anemia 3. agranulocytosis 7. eosinophilia 4. hemolytic anemia Dermatologic-Hypersensitivity Reactions 1. toxic epidermal necrolysis 7. bullous pemphigoid 2. Stevens-Johnson Syndrome 8. purpura 3. erythema multiforme 9. fever 4. drug rash with eosinophilia and systemic symptoms 10. rash 5. acute generalized exanthematous pustulosis 11. pruritus 6. exfoliative dermatitis 12. urticaria Cardiovascular Reaction 1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. 2. Increase in cholesterol and triglyceride serum levels Other Reactions 1. hyperglycemia 6. restlessness 2. glycosuria 7. urinary bladder spasm 3. hyperuricemia 8. thrombophlebitis 4. muscle spasm 9. fever 5. weakness Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table
<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr><td styleCode="Toprule" rowspan="2" valign="top"><paragraph/><paragraph> 1. hepatic encephalopathy in patients with hepatocellular insufficiency</paragraph></td><td styleCode="Toprule" valign="top"><paragraph/><paragraph> 6. oral and gastric irritation</paragraph></td></tr><tr><td valign="top"> 7. cramping</td></tr><tr><td valign="top"><paragraph>2. pancreatitis</paragraph></td><td valign="top"><paragraph>8. diarrhea</paragraph></td></tr><tr><td valign="top"><paragraph/><paragraph> 3. jaundice (intrahepatic cholestatic jaundice)</paragraph></td><td valign="top"><paragraph>9. constipation</paragraph></td></tr><tr><td valign="top"><paragraph>4. increased liver enzymes</paragraph></td><td valign="top"><paragraph>10. nausea</paragraph></td></tr><tr><td styleCode="Botrule" valign="top"><paragraph>5. anorexia</paragraph></td><td styleCode="Botrule" valign="top"> 11. vomiting</td></tr></tbody></table>
adverse reactions table
<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr><td styleCode="Toprule" valign="top"><paragraph/><paragraph> 1. severe anaphylactic or anaphylactoid reactions (e.g., with shock)</paragraph></td><td styleCode="Toprule" valign="top"><paragraph>3. interstitial nephritis</paragraph></td></tr><tr><td styleCode="Botrule" valign="top"><paragraph/><paragraph> 2. systemic vasculitis</paragraph></td><td styleCode="Botrule" valign="top"><paragraph>4. necrotizing angiitis</paragraph></td></tr></tbody></table>
adverse reactions table
<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr><td styleCode="Toprule" valign="top"><paragraph>1. tinnitus and hearing loss</paragraph></td><td styleCode="Toprule" valign="top"><paragraph>5. headache</paragraph></td></tr><tr><td valign="top"><paragraph>2. paresthesias</paragraph></td><td valign="top"><paragraph>6. blurred vision</paragraph></td></tr><tr><td valign="top"><paragraph>3. vertigo</paragraph></td><td valign="top"><paragraph>7. xanthopsia</paragraph></td></tr><tr><td styleCode="Botrule" valign="top"><paragraph>4. dizziness</paragraph></td><td styleCode="Botrule" valign="top"/></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.