FDA.reportPublic FDA data

SulfatrimTM Pediatric Suspension

Manufacturer
TriRx Huntsville Pharmaceutical Services
Effective date
2024-06-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:01:16

Label at a glance#

ProductSulfatrimTM Pediatric Suspension
Active ingredientTRIMETHOPRIM, SULFAMETHOXAZOLE
Label structure28 sections

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

DescriptionDescription

Inactive Ingredient Section

Inactive IngredientsInactive Ingredients

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

Clinical PharmacologyClinical Pharmacology

Geriatric Pharmacokinetics

PHARMACOKINETICS SECTION

Geriatric PharmacokineticsGeriatric Pharmacokinetics

Microbiology 2

MICROBIOLOGY SECTION

Microbiology 2Microbiology 2

Microbiology 1

MICROBIOLOGY SECTION

Microbiology 1Microbiology 1

Microbiology 3

MICROBIOLOGY SECTION

Microbiology 3Microbiology 3

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Contraindications

CONTRAINDICATIONS SECTION

ContraindicationsContraindications

Warnings 1

WARNINGS SECTION

Warnings 1Warnings 1

Warnings 2

WARNINGS SECTION

Warnings 2Warnings 2

Precautions

PRECAUTIONS SECTION

PrecautionsPrecautions

Information for Patients

INFORMATION FOR PATIENTS SECTION

Information for PatientsInformation for Patients

Laboratory Tests

LABORATORY TESTS SECTION

Laboratory TestsLaboratory Tests

Drug Interactions

DRUG INTERACTIONS SECTION

Drug InteractionsDrug Interactions

Drug Laboratory Test Interactions

DRUG INTERACTIONS SECTION

Drug Laboratory Test InteractionsDrug Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

CarcinogenesisCarcinogenesis

Pregnancy 1

PREGNANCY SECTION

Pregnancy 1Pregnancy 1

Pregnancy 2

PREGNANCY SECTION

Pregnancy 2Pregnancy 2

Geriatric Use

GERIATRIC USE SECTION

Geriatric UseGeriatric Use

Adverse Reactions 1

ADVERSE REACTIONS SECTION

Adverse Reactions 1Adverse Reactions 1

Adverse Reactions 2

ADVERSE REACTIONS SECTION

Adverse Reactions 2Adverse Reactions 2

Overdosage

OVERDOSAGE SECTION

OverdosageOverdosage

Dosage and Administration 1

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration 1Dosage and Administration 1

Dosage and Administration 2

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration 2Dosage and Administration 2

How Supplied

HOW SUPPLIED SECTION

How SuppliedHow Supplied

References

REFERENCES SECTION

ReferencesReferences

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80432-06580432-065-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
TRIMETHOPRIMAN164J8Y0XACTIB
SUCROSEC151H8M554IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPYLPARABENZ8IX2SC1OHIACT
SULFAMETHOXAZOLEJE42381TNVACTIB
METHYLPARABENA2I8C7HI9TIACT
ALCOHOL3K9958V90MIACT
CHERRYBUC5I9595WIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
19fed1fd-3cc4-6755-e063-6294a90ae36719fed1fd-3cc3-6755-e063-6294a90ae3672024-06-03Warnings, Adverse reactionsExact identifier
spl id: 19fed1fd-3cc4-6755-e063-6294a90ae367
spl set id: 19fed1fd-3cc3-6755-e063-6294a90ae367

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.