EXTRA STRENGTH
KAOPECTATE Extra Strength Gas Relief Liquid
Approved
Approval ID
d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
KRAMER LABORATORIES
DUNS: 122720675
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SIMETHICONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55505-225
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
SIMETHICONE
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (13)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DIMETHICONE, UNSPECIFIEDActive
Quantity: 125 mg in 5 mL
Code: 92RU3N3Y1O
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/20/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 11/20/2023
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 11/20/2023
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 11/20/2023
WARNINGS SECTION
LOINC: 34071-1Updated: 11/20/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 11/20/2023
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 11/20/2023
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 11/20/2023
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 11/20/2023