BERKLEY JENSEN
Ultra Strength Antacid Tablets Calcium Carbonate Drug Facts
Approved
Approval ID
c7eedcbf-3b07-4cd3-937b-c56d7cc5bc57
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
BJWC
DUNS: 159082692
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ANTACID CALCIUM CARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68391-033
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
ANTACID CALCIUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT