Ferrous Sulfate
Ferrous SulfateIron supplement therapy
Approved
Approval ID
38104333-f334-4d97-8657-94a00942faf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2017
Manufacturers
FDA
Healthlife of USA
DUNS: 079656178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iron Supplement Therapy
PRODUCT DETAILS
NDC Product Code69517-133
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateDecember 20, 2017
Generic NameIron Supplement Therapy
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROUS SULFATEActive
Quantity: 65 mg in 1 1
Code: 39R4TAN1VT
Classification: ACTIM
CALCIUM PHOSPHATEInactive
Code: 97Z1WI3NDX
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/5/2017
Storage
Store in a cool, dry place.
Protect contents from light and moisture. you may report side effects by calling 1-844-221-7294.
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/5/2017
Amount per serving
Iron (as dried ferrous sulfate) 65mg.............360%