Label: SULFAMETHOXAZOLE AND TRIMETHOPRIM suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 16, 2025

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  • SPL UNCLASSIFIED SECTION
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and ...
  • DESCRIPTION
    Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 ...
  • CLINICAL PHARMACOLOGY
    Sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. Both sulfamethoxazole and trimethoprim exist in the blood as unbound, protein-bound and metabolized forms ...
  • INDICATIONS AND USAGE
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and ...
  • CONTRAINDICATIONS
    Sulfamethoxazole and trimethoprim oral suspension is contraindicated in the following situations: known hypersensitivity to trimethoprim or sulfonamides - history of drug-induced immune ...
  • WARNINGS
    Embryofetal Toxicity - Some epidemiologic studies suggest that exposure to sulfamethoxazole and trimethoprim during pregnancy may be associated with an increased risk of congenital malformations ...
  • PRECAUTIONS
    Development of Drug Resistant Bacteria - Prescribing sulfamethoxazole and trimethoprim oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic ...
  • ADVERSE REACTIONS
    The following adverse reactions associated with the use of sulfamethoxazole and trimethoprim oral suspension or sulfamethoxazole and trimethoprim were identified in clinical trials, postmarketing ...
  • OVERDOSAGE
    Acute - The amount of a single dose of sulfamethoxazole and trimethoprim that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs ...
  • DOSAGE AND ADMINISTRATION
    Sulfamethoxazole and trimethoprim oral suspension is contraindicated in pediatric patients less than 2 months of age. Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients ...
  • HOW SUPPLIED
    Sulfamethoxazole and Trimethoprim Oral Suspension, USP contains 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL). Available as a pink, cherry-flavored syrup suspension ...
  • REFERENCES
    Kremers P, Duvivier J, Heusghem C. Pharmacokinetic Studies of Co-Trimoxazole in Man after Single and Repeated Doses. J Clin Pharmacol. Feb-Mar 1974; 14:112–117. Kaplan SA, et al ...
  • PACKAGING INFORMATION
    American Health Packaging unit dose cups (see - How Supplied section) contain drug product from Aurobindo Pharma USA, Inc. as follows: (800 mg/160 mg per 20 mL / 40 UD) NDC 60687-442-75 ...
  • Package/Label Display Panel
    Sulfamethoxazole and - Trimethoprim Oral - Suspension, USP - Rx Only - Contains alcohol 0.04% and added - as preservatives methylparaben 0.1%, sodium benzoate 0.1% CHERRY ...
  • Package/Label Display Panel
    Rx Only - NDC 60687- 442-24 - Sulfamethoxazole - and Trimethoprim - Oral Suspension, USP - 800 mg/160 mg per 20 mL - Alcohol 0.04% CHERRY FLAVOR - Delivers 20 mL - Protect from ...
  • INGREDIENTS AND APPEARANCE
    Product Information