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

----------

PAI Sulfatrim Pediatric Suspension

Description

Description

Inactive Ingredient Section

Inactive Ingredients

Clinical Pharmacology

Clinical Pharmacology

Geriatric Pharmacokinetics

Geriatric Pharmacokinetics

Microbiology 2

Microbiology 2

Microbiology 1

Microbiology 1

Microbiology 3

Microbiology 3

Indications and Usage

Indications and Usage

Contraindications

Contraindications

Warnings 1

Warnings 1

Warnings 2

Warnings 2

Precautions

Precautions

Information for Patients

Information for Patients

Laboratory Tests

Laboratory Tests

Drug Interactions

Drug Interactions

Drug Laboratory Test Interactions

Drug Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Pregnancy 1

Pregnancy 1

Pregnancy 2

Pregnancy 2

Geriatric Use

Geriatric Use

Adverse Reactions 1

Adverse Reactions 1

Adverse Reactions 2

Adverse Reactions 2

Overdosage

Overdosage

Dosage and Administration 1

Dosage and Administration 1

Dosage and Administration 2

Dosage and Administration 2

How Supplied

How Supplied

References

References

Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - TriRx Huntsville Pharmaceutical Services (117090286)

Revised: 6/2024

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

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

Version: 1

Effective Time: 20240603

TriRx Huntsville Pharmaceutical Services