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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
Effective Date
May 23, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Calcium carbonate(675 mg in 1 1)
Magnesium hydroxide(135 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
10267-0020
Route of Administration
ORAL
Effective Date
May 23, 2025
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
Code: H0G9379FGKClass: ACTIBQuantity: 675 mg in 1 1
Code: NBZ3QY004SClass: ACTIBQuantity: 135 mg in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MINTInactive
Code: FV98Z8GITPClass: IACT
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SUCROSEInactive
Code: C151H8M554Class: 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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