Calcium Carbonate Antacid Assorted Berries
CM Extra Strength Antacid (750 mg) Assorted Berry
Approved
Approval ID
e07b3ec8-c2c7-41da-8374-12fe9f09d856
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
FSA STORE INC.
DUNS: 049283340
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 Code81522-361
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 750 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/18/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/18/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/18/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 4/18/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/18/2025
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 4/18/2025