FDA.reportPublic FDA data

acetaminophen aspirin and caffeine

Manufacturer
Elysium Pharmaceutical Ltd
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:53:20

Label at a glance#

Productacetaminophen aspirin and caffeine
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE SECTION

Analgesic and Antipyretic 

DOSAGE & ADMINISTRATION SECTION

FOR MANUFACTURING, PROCESSING OR REPACKING

WARNINGS SECTION

KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose

OTC - PURPOSE SECTION

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14803-13514803-135-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
N-VINYLPYRROLIDINONE76H9G81541IACT
STEARIC ACID4ELV7Z65APIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB

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
49715a86-f118-2f36-e063-6394a90a09081031c81e-ac26-4068-e063-6394a90a6e9d2026-01-28WarningsExact identifier
spl id: 49715a86-f118-2f36-e063-6394a90a0908
spl set id: 1031c81e-ac26-4068-e063-6394a90a6e9d

Reported adverse events (FAERS/openFDA)#

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