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FDA Approval

Calcium Carbonate, Magnesium Hydroxide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Contract Pharmacal Corp.
DUNS: 057795122
Effective Date
June 16, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Magnesium hydroxide(200 mg in 1 1)
Calcium carbonate(1000 mg in 1 1)

Products1

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

NDC Product Code
10267-0041
Route of Administration
ORAL
Effective Date
June 16, 2025
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6QClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
MALIC ACIDInactive
Code: 817L1N4CKPClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01Class: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21JClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
Code: NBZ3QY004SClass: ACTIBQuantity: 200 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
Code: H0G9379FGKClass: ACTIBQuantity: 1000 mg in 1 1
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P&G Label


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