PAI Sulfatrim Pediatric Suspension

SulfatrimTM Pediatric Suspension by

Drug Labeling and Warnings

SulfatrimTM Pediatric Suspension by is a Prescription medication manufactured, distributed, or labeled by TriRx Huntsville Pharmaceutical Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SULFATRIMTM PEDIATRIC SUSPENSION- sulfamethoxazole and trimethoprim oral suspension liquid 
TriRx Huntsville Pharmaceutical Services

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PAI Sulfatrim Pediatric Suspension

Description

Inactive Ingredient Section

Clinical Pharmacology

Geriatric Pharmacokinetics

Microbiology 2

Microbiology 1

Microbiology 3

Indications and Usage

Contraindications

Warnings 1

Warnings 2

Precautions

Information for Patients

Laboratory Tests

Drug Interactions

Drug Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy 1

Pregnancy 2

Geriatric Use

Adverse Reactions 1

Adverse Reactions 2

Overdosage

Dosage and Administration 1

Dosage and Administration 2

How Supplied

References

Label

SULFATRIMTM PEDIATRIC SUSPENSION 
sulfamethoxazole and trimethoprim oral suspension liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80432-065
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)	TRIMETHOPRIM	40 mg  in 5 mL
SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV)	SULFAMETHOXAZOLE	200 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
CHERRY (UNII: BUC5I9595W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80432-065-33	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018615	04/29/2024

Labeler - TriRx Huntsville Pharmaceutical Services (117090286)

Revised: 6/2024

Document Id: 19fed1fd-3cc4-6755-e063-6294a90ae367

34391-3

Set id: 19fed1fd-3cc3-6755-e063-6294a90ae367

Version: 1

Effective Time: 20240603