Aspirin 81mg

Manufacturer
VITANE PHARMACEUTICALS, INC | Aarkish Pharmaceuticals, NJ 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. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 81 mg Aspirin.

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, 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°and 30°C (59°and 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.

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • ask your doctor about other uses for enteric-coated 81 mg Aspirin.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

corn starch, pregelatinized starch, povidone, microcrystalline celulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.

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

Aspirin may cause a severe allergic reaction which may include:

- hives

- facial swelling

- shock

- asthma (wheezing)

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 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 SECTION

OTC - DO NOT 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, have bloody or black stools, vomit blood, 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

these could be signs of a serious condition.

ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

- taking a prescription drug for gout, diabetes, or arthritis

- taking any other medication

- under a doctor’s care for any serious condition

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, have bloody or black stools, vomit blood, 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

these could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING SECTION

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.

ASK A DOCTOR BEFORE USE

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

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
  • you have asthma

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 right away (1-800-222-1222).

STORAGE

STORAGE AND HANDLING SECTION

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

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, not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: Consult a doctor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60577-807-01

Vitane's

Aspirin 81mg

Pain Reliever -

Aspirin USP 81 mg (NSAID) Enteric Coated

60 tablets

ASPIRIN LABELASPIRIN 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 IFC_ECE808R2_(Aarkish Pharma) 10132025 (2) (1)_page-0001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
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bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60577-807-01Aspirin 81mg60 in 1 BOTTLETABLET601
60577-807-01Aspirin 81mg1 in 1 CARTONTABLET11

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60577-80760577-807-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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, INC4138d4c0-baa5-1f20-e063-6394a90a788f2025-10-15WarningsExact identifier
ndc (package): 60577-807-01
ndc (product): 60577-807
ndc11 (package): 60577080701
spl id: 4138d4c0-baa6-1f20-e063-6394a90a788f
spl set id: 4138d4c0-baa5-1f20-e063-6394a90a788f

Reported adverse events (FAERS/openFDA)#

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