MedPath
FDA Approval

Adult Low Dose Enteric Coated Aspirin

April 8, 2025

HUMAN OTC DRUG LABEL

Aspirin(81 mg in 1 1)

Manufacturing Establishments (1)

NuCare Pharmaceuticals, Inc.

NuCare Pharmaceuticals, Inc.

010632300

Products (1)

Adult Low Dose Enteric Coated Aspirin

68071-3829

M013

OTC Monograph Drug (C200263)

ORAL

April 8, 2025

SHELLACInactive
Code: 46N107B71OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
AspirinActive
Code: R16CO5Y76EClass: ACTIBQuantity: 81 mg in 1 1
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