MedPath

Ki No Sin

84540-323 Ki No Sin capsule

Approved
Approval ID

20cf8f80-c638-4d94-e063-6294a90a5400

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

NPG Bio Pharmaceuticals Co.,Ltd.

DUNS: 963309698

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Calcium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84540-323
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (17)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
GARDENIA JASMINOIDES FRUITInactive
Code: 7CTH8MD549
Classification: IACT
WINE GRAPE JUICEInactive
Code: JHQ6158A7R
Classification: IACT
CHOLECALCIFEROLInactive
Code: 1C6V77QF41
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLUCOSAMINE HYDROCHLORIDEInactive
Code: 750W5330FY
Classification: IACT
GINKGOInactive
Code: 19FUJ2C58T
Classification: IACT
BOMBYX MORI FIBERInactive
Code: 6LK42KUV6W
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 55 mg in 500 mg
Code: H0G9379FGK
Classification: ACTIB
NELUMBO NUCIFERA LEAFInactive
Code: 60C608DPVT
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
POLIGLUSAMInactive
Code: 82LKS4QV2Y
Classification: IACT
CYANOCOBALAMINInactive
Code: P6YC3EG204
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/4/2024

Label

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/4/2024

Uses

This health supplement can be used to aid in the improvement of body functions compromised by diabetes and kidney disease, and to help maintain normal calcium ion levels.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/4/2024

Active Ingredients

Calcium Carbonate (CaCO3) 5.5%, 55 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/4/2024

Purposes

Promotes overall health and wellness for those managing diabetes and kidney conditions by providing essential support. Helps to regulate and normalize the body’s critical signaling processes for improved physiological function.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/4/2024

Warnings

if you are sensitive to any of the ingredients in this product.

Consult a healthcare professional before use if you are pregnant or breastfeeding.

Do not exceed the recommended dosage.

Swallow with sufficient water or a beverage to prevent aspiration.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/4/2024

Warnings

Keep out of reach of children

Pregnant women are advised to consult with their healthcare provider prior to use.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/4/2024

Warnings

Stop use and ask a doctor if

symptoms persist or get worse.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/4/2024

Warnings

When using this product

do not use more than directed.

take with enough water or drink to avoid getting into airway.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/4/2024

Warnings

Ensure that the included desiccant is not ingested.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2024

Directions

Adults and teenagers (18+ years): Take 2 tablets 2-3 times daily.

Children aged 12-18 years: Take 1 tablet once daily.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2024

Inactive Ingredients

Microcrystalline Cellulose, Chitosan, lactose, Gardenia Florida Fruit Extract, Gardenia Jasminoides Fruit Extract, Magnesium Oxide, Maltodextrin, Vitis Vinifera (Grape) Juice Powder, Hydroxypropyl Methylcellulose, Flavor, Cyanocobalamin, Magnesium Stearate, Cholecalciferol, Zinc Oxide, Glucosamine Hydrochloride, Ginkgo Biloba Leaf Extract, Nelumbo Nucifera (Lotus) Leaf Powder, Silk Extract

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Ki No Sin - FDA Drug Approval Details