Label: GRISEOFULVIN ORAL SUSPENSION suspension

  • NDC Code(s): 80432-056-11
  • Packager: TriRx Huntsville Pharmaceutical Services LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 10, 2023

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  • ADVERSE REACTIONS

    Adverse Reactions

    Adverse reactions 2

  • CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

    CMF-1

    CMF-2

  • CLINICAL PHARMACOLOGY

    Clinical Pharmacology

    Clinical Pharmacology-2

    Clinical Pharmacology-3

  • CONTRAINDICATIONS

    Contraindications-1

    Contraindications-2

    Contraindications-3

  • DESCRIPTION

    Description-2Description-1

  • DOSAGE & ADMINISTRATION

    Dosage and Administration-1

    Dosage and Administration-2

    dosage and administration 3

    Dosage and Administration-4

    dosage and administration 4

  • DRUG INTERACTIONS

    Drug Interactions-1

    drug interactions-2

  • HOW SUPPLIED

    How Supplied

  • INDICATIONS & USAGE

    Indications and Usage-1

    Indications and Usage-2

    Indications and Usage-3

  • MICROBIOLOGY

    microbiology

  • OVERDOSAGE

    Overdosage

  • PEDIATRIC USE

    Pediatric Use

  • PRECAUTIONS

    Precautions

  • PREGNANCY

    pregnancy

  • WARNINGS

    Warnings and Precautions

    Hepatotoxicity

  • NURSING MOTHERS

    Nursing Mothers

  • PRINCIPAL DISPLAY PANEL

    primary package label-bottle

  • INGREDIENTS AND APPEARANCE
    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)
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