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ValuMeds Extra Strength Headache Relief

ValuMeds Extra Strength Headache Relief, Acetaminophen, Aspirin and Caffeine

Approved
Approval ID

0f864e73-e4b8-4e23-8990-8439ac17bd58

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 31, 2025

Manufacturers
FDA

Cabinet Health P.B.C.

DUNS: 117102391

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ACETAMINOPHEN, ASPIRIN, CAFFEINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82725-1023
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
ACETAMINOPHEN, ASPIRIN, CAFFEINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2025
FDA Product Classification

INGREDIENTS (11)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CAFFEINEActive
Quantity: 65 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
ASPIRINActive
Quantity: 250 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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ValuMeds Extra Strength Headache Relief - FDA Drug Approval Details