Griselfulvin Oral Suspension, USP

Griseofulvin Oral Suspension by

Drug Labeling and Warnings

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

Drug Details [pdf]

GRISEOFULVIN ORAL SUSPENSION- griseofulvin oral suspension suspension 
TriRx Huntsville Pharmaceutical Services LLC

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Griselfulvin Oral Suspension, USP

Adverse Reactions

Adverse reactions 2

CMF-1

CMF-2

Clinical Pharmacology

Clinical Pharmacology-2

Clinical Pharmacology-3

Contraindications-1

Contraindications-2

Contraindications-3

Description-2Description-1

Dosage and Administration-1

Dosage and Administration-2

dosage and administration 3

Dosage and Administration-4

dosage and administration 4

Drug Interactions-1

drug interactions-2

How Supplied

Indications and Usage-1

Indications and Usage-2

Indications and Usage-3

microbiology

Overdosage

Pediatric Use

Precautions

pregnancy

Warnings and Precautions

Hepatotoxicity

Nursing Mothers

primary package label-bottle

GRISEOFULVIN ORAL SUSPENSION 
griseofulvin oral suspension suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 80432-056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5) GRISEOFULVIN125 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ORANGE (UNII: 5EVU04N5QU)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
MENTHOL, (+)- (UNII: C6B1OE8P3W)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SUCROSE (UNII: C151H8M554)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80432-056-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06543808/09/2022
Labeler - TriRx Huntsville Pharmaceutical Services LLC (117090286)
Establishment
NameAddressID/FEIBusiness Operations
TriRx Huntsville Pharmaceutical Services117090286manufacture(80432-056)

Revised: 1/2023
Document Id: f1ea506d-0062-7849-e053-2995a90a94ea
Set id: f1ea506d-0061-7849-e053-2995a90a94ea
Version: 1
Effective Time: 20230110
 
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