KO-LANTA
Geri-lanta original 629
Approved
Approval ID
31a6011d-5c61-d0fe-e063-6294a90ac589
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
Geri-Care Pharmaceuticals, Corp
DUNS: 611196254
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aluminum hydroxide, magnesium hydroxide, dimethicone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57896-004
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide, magnesium hydroxide, dimethicone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (10)
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
DIMETHICONEActive
Quantity: 20 mg in 5 mL
Code: 92RU3N3Y1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 200 mg in 5 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 200 mg in 5 mL
Code: NBZ3QY004S
Classification: ACTIB