FDA.reportPublic FDA data

Aspirin - HHH Pharmaceuticals | ELYSIUM PHARMACEUTICALS LIMITED

Manufacturer
HHH Pharmaceuticals | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:05

Label at a glance#

ProductAspirin 81mg Enteric Coated
Active ingredientASPIRIN
Label structure10 sections

Indications and uses

temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: • take 4 to 8 tablets every 4 hours while symptoms last • not to take more than 48 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

store at room temperature 15-30ºC (59-86ºF) read all product information before using

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses:

INDICATIONS & USAGE SECTION

  • temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Warnings

WARNINGS SECTION

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

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 steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs.

Seek medical help right away.

  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling present in the painful area
  • new symptoms occur

These could be sign of a serious condition

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • adults and children 12 years and over:
    • take 4 to 8 tablets every 4 hours while symptoms last
    • not to take more than 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years:ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15-30ºC (59-86ºF)
  • read all product information before using

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Yellow Oxide of Iron, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate.

Questions or comments?

OTC - QUESTIONS SECTION

Call +1 848-235-5293 Monday through Friday 9AM-4PM EST

PRINCIPAL DISPLAY PANEL-500's Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

PRINCIPAL DISPLAY PANEL-1000's Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN2
308416aspirin 81 MG Delayed Release Oral TabletSCD2
308416ASA 81 MG Delayed Release Oral TabletSY2
308416aspirin 81 MG Enteric Coated Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383586104059GTIN-13: 0383586104059
EAN-13: 0383586104059
GTIN-12: 383586104059
UPC-A: 383586104059
GTIN storage (14 digits): 00383586104059		label-500.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83586-104-05Aspirin 81mg Enteric Coated1000 in 1 BOTTLETABLET, DELAYED RELEASE10002
83586-104-10Aspirin 81mg Enteric Coated500 in 1 BOTTLETABLET, DELAYED RELEASE5002

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83586-10483586-104-05, 83586-104-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
LACTOSEJ2B2A4N98GIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TALC7SEV7J4R1UIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ASPIRINR16CO5Y76EACTIB

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
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact identifier
ndc (package): 83586-104-05
ndc (package): 83586-104-10
ndc (product): 83586-104
ndc11 (package): 83586010405
ndc11 (package): 83586010410
spl id: 511f455b-cb98-e38f-e063-6394a90a24af
spl set id: d81aec73-c7c1-4c52-80f6-fb0e32caf7aa

Reported adverse events (FAERS/openFDA)#

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