FDA.reportPublic FDA data

Aspirin 81 mg

Manufacturer
AACE Pharmaceuticals, Inc.
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:49:32

Label at a glance#

ProductAspirin 81 mg
Active ingredientASPIRIN
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: - are age 60 or older - have had stomach ulcers or bleeding problems - take a blood thinning (anticoagulant) or steriod drug - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for longer time than directed

INDICATIONS & USAGE SECTION

Pin Reliever

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71406-128-12 AACE Pharmaceuticals - Adult Low Strength - Pain Reliever - Aspirin USP 81 mg (NSAID) Enteric Coated - 120 tablets - Compare to Active Ingredient in Aspirin Regimen BAYER®

Aspirin 120 JPG 1Aspirin 120 JPG 1Aspirin 120 JPG 2Aspirin 120 JPG 2NDC 71406-128-10 AACE Pharmaceuticals - Adult Low Strength - Pain Reliever - Aspirin USP 81 mg (NSAID) Enteric Coated - 1000 tablets - Compare to Active Ingredient in Aspirin Regimen BAYER®

Aspirin 1000 JPG 1Aspirin 1000 JPG 1Aspirin 1000 JPG 2Aspirin 1000 JPG 2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71406-128-10EA - Each71406-128ba1e361e-bbbe-4e71-aa9a-1982b0ae106612021-11-09
71406-128-12EA - Each71406-128d026f40a-0608-4bb3-b1e6-d53c51eb850612021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71406-12871406-128-10, 71406-128-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIACETINXHX3C3X673IACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM LAURYL SULFATE368GB5141JIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ASPIRINR16CO5Y76EACTIB
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TALC7SEV7J4R1UIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MICROCRYSTALLINE CELLULOSE 2005XDI2TS1EZIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
351de7c2-98c2-7c88-e063-6294a90ad811c3635e98-93cf-0e1e-e053-2a95a90ab7b92025-05-14WarningsExact identifier
spl set id: c3635e98-93cf-0e1e-e053-2a95a90ab7b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.