Aspirin 81mg

Manufacturer
VITANE PHARMACEUTICALS, INC | InvaHealth Inc
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:09

Label at a glance#

ProductAspirin 81mg
Active ingredientASPIRIN
Label structure16 sections

Indications and uses

Temporarily relieves minor aches and pains For use as directed by a doctor for the prevention of recurrent heart attack or stroke Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Dosage and administration

Directions: drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Storage and handling

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F–86°F) Use by expiration date on package.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

PURPOSE

OTC - PURPOSE SECTION

Pain reliever

USES

INDICATIONS & USAGE SECTION

  • Temporarily relieves minor aches and pains
  • For use as directed by a doctor for the prevention of recurrent heart attack or stroke

Because of its delayed 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

OTHER SAFETY INFORMATION

Allergy Alert:

  • Aspirin may cause a severe allergic reaction which may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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 steroid drug
  • take other drugs containing prescription or non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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 SECTION

OTC - DO NOT USE SECTION

Do not use if:

You are allergic to aspirin or any other pain reliever/fever reducer.

ASK A DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • an allergic reaction occurs.
  • Seek medical help right away
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs.

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional.

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 SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions:

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

STORAGE

STORAGE AND HANDLING SECTION

  • Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F–86°F)
  • Use by expiration date on package.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6

ASK A DOCTOR BEFORE USE

OTC - ASK DOCTOR SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60577-808-01

Vitane's

Aspirin 81mg

Pain Reliever

Aspirin 81 mg (NSAID) Enteric Coated

60 tablets

Aspirin 81mg LabelAspirin 81mg LabelASPIRIN 81 mg IFCASPIRIN 81 mg IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN1
308416aspirin 81 MG Delayed Release Oral TabletSCD1
308416ASA 81 MG Delayed Release Oral TabletSY1
308416aspirin 81 MG Enteric Coated Oral TabletSY1

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-130815544021271GTIN-13: 0815544021271
EAN-13: 0815544021271
GTIN-12: 815544021271
UPC-A: 815544021271
GTIN storage (14 digits): 00815544021271
Aspirin 81mg carton ECE808R1 09.24.2025_Revised (1)_page-0001.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
60577-808-01Aspirin 81mg60 in 1 BOTTLETABLET, DELAYED RELEASE601
60577-808-01Aspirin 81mg1 in 1 CARTONTABLET, DELAYED RELEASE11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60577-80860577-808-01

Ingredients#

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

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

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 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC41386de5-5857-efab-e063-6294a90afd9c2025-10-15WarningsExact identifier
ndc (package): 60577-808-01
ndc (product): 60577-808
ndc11 (package): 60577080801
spl id: 41386de5-5858-efab-e063-6294a90afd9c
spl set id: 41386de5-5857-efab-e063-6294a90afd9c

Reported adverse events (FAERS/openFDA)#

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