Kaopectate Vanilla Flavor Anti Diarrheal
Drug Facts
Approved
Approval ID
3ad310c8-3dfa-4435-87bf-17f1c0a9ca45
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.
bismuth subsalicylate
PRODUCT DETAILS
NDC Product Code55505-198
Application NumberM008
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateApril 17, 2025
Generic Namebismuth subsalicylate
INGREDIENTS (8)
Bismuth SubsalicylateActive
Quantity: 262 mg in 15 mL
Code: 62TEY51RR1
Classification: ACTIB
Carboxymethylcellulose Sodium, UnspecifiedInactive
Code: K679OBS311
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Sodium SalicylateInactive
Code: WIQ1H85SYP
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/15/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 11/15/2023
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/7/2022
WARNINGS SECTION
LOINC: 34071-1Updated: 11/15/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 11/15/2023
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 11/15/2023
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 11/15/2023