MedPath

R Cos

84540-523 R Cos ​capsule

Approved
Approval ID

21469f58-1d70-774f-e063-6294a90af039

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 Code84540-523
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 (26)

OPHIOCORDYCEPS SINENSISInactive
Code: 8Q1GYP08KU
Classification: IACT
GARDENIA JASMINOIDES FRUITInactive
Code: 7CTH8MD549
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
LYSINE HYDROCHLORIDEInactive
Code: JNJ23Q2COM
Classification: IACT
VALINEInactive
Code: HG18B9YRS7
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
BOMBYX MORI FIBERInactive
Code: 6LK42KUV6W
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
WINE GRAPE JUICEInactive
Code: JHQ6158A7R
Classification: IACT
CYANOCOBALAMINInactive
Code: P6YC3EG204
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 90 mg in 500 mg
Code: H0G9379FGK
Classification: ACTIB
ISOMALTULOSE ANHYDROUSInactive
Code: V59P50X4UY
Classification: IACT
ISOLEUCINEInactive
Code: 04Y7590D77
Classification: IACT
PHYTONADIONEInactive
Code: A034SE7857
Classification: IACT
NELUMBO NUCIFERA LEAFInactive
Code: 60C608DPVT
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CHOLECALCIFEROLInactive
Code: 1C6V77QF41
Classification: IACT
PHENYLALANINEInactive
Code: 47E5O17Y3R
Classification: IACT
ASIAN GINSENGInactive
Code: CUQ3A77YXI
Classification: IACT
LEUCINEInactive
Code: GMW67QNF9C
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Label

label84540-501 R Cos

INDICATIONS & USAGE SECTION

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

Uses

A dietary supplement to support the immune system and help alleviate symptoms associated with various viral and bacterial infections, such as those caused by COVID-19 and MERS.
Depending on the stmptoms, it may be taken alongside antipyretics, expectorants, and analgesics.

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredients

Calcium Carbonate (CaCO3) 18%...............180 mg

OTC - PURPOSE SECTION

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

Purposes

This supplement may support the immune system and help alleviate symptoms associated with various viral and bacterial infections, such as those caused by COVID-19 and MERS. Depending on the symptoms, it may be taken alongside antipyretics, expectorants, and analgesics.

OTC - DO NOT USE SECTION

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

Warnings

Do not use 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.

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

Microcrystalline Cellulose, Lactose, Magnesium Oxide, Gardenia Florida Fruit Extract,Gardenia Jasminoides Fruit Extract, Maltodextrin, L-Phenylalanine, L-Leucine, L-Methionine, L-Lysine Hydrochloride, Palatinose, L-Isoleucine,Leucine,Isoleucine,Valine

Ascorbic Acid, Vitis Vinifera (Grape) Juice Powder, Flavor

Cyanocobalamin, Hydroxypropyl Methylcellulose, Phytonadione

Zinc Oxide, Corn Starch, Panax Ginseng Root Powder. Silica

Cholecalciferol, Silk Extract, Cordyceps Sinensis Extract, Nelumbo Nucifera (Lotus) Leaf Powder

DOSAGE & ADMINISTRATION SECTION

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

Directions

For teenagers and adults (18+ years): Take 2 tablets once or twice daily.

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

For children aged 8-12 years: Take ½ tablet once daily.

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