Calcium Carbonate, Magnesium Hydroxide
5758- Export
Approved
Approval ID
37b5a755-a766-734d-e063-6294a90a7b88
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Jun 16, 2025
Manufacturers
FDA
Contract Pharmacal Corp.
DUNS: 057795122
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcium Carbonate, Magnesium Hydroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10267-0041
Product Classification
G
Generic Name
Calcium Carbonate, Magnesium Hydroxide
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2025
FDA Product Classification
INGREDIENTS (23)
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MAGNESIUM HYDROXIDEActive
Quantity: 200 mg in 1 1
Code: NBZ3QY004S
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 6/18/2025
