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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69517-133
Product Classification
G
Generic Name
Iron Supplement Therapy
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2017
FDA Product Classification
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%