Aspirin

Manufacturer
Aarkish Pharmaceuticals NJ Inc.
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:13

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure15 sections

Indications and uses

temporarily relieves minor aches and pains Because of its delayed action, this product will not produce 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°-30°C (59°-86°F) - Use by expiration date on package

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory 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 produce fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for enteric-coated 81 mg Aspirin

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 early sign of Reye's syndrome, a rare but serious illness.



OTHER SAFETY INFORMATION

SPL UNCLASSIFIED SECTION

Allergy Alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- shock
- 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 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

DO NOT USE

OTC - DO NOT USE SECTION

Do not use: if you are allergic to aspirin or any other pain reliever/fever reducer

ASK DOCTOR

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
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea

ASK A DOCTOR OR PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if

 - an allergic reaction occurs. Seek medical help right away.
- you are 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 a loss of hearing occurs.
these could be signs of a serious condition.

PREGNANCY OR BREASTFEEDING

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

STORAGE

STORAGE AND HANDLING SECTION

- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- Use by expiration date on package

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, pregelatinized starch, povidone, microcrystalline cellulose, 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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin Tablets, 81 mg, 300 counts

aspirin-cont-label-1-front.jpgaspirin-cont-label-1-front.jpg

aspirin-cont-label-1-back.jpgaspirin-cont-label-1-back.jpg

Aspirin Tablets, 81 mg, 1000 counts

aspirin-cont-label-2-front.jpgaspirin-cont-label-2-front.jpgaspirin-cont-label-2-back.jpgaspirin-cont-label-2-back.jpg

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-130381005103300GTIN-13: 0381005103300
EAN-13: 0381005103300
GTIN-12: 381005103300
UPC-A: 381005103300
GTIN storage (14 digits): 00381005103300
aspirin-cont-label-1-front.jpg.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
81005-103-10Aspirin1000 in 1 BOTTLETABLET, COATED10001
81005-103-30Aspirin300 in 1 BOTTLETABLET, COATED3001

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81005-10381005-103-30, 81005-103-10

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
AspirinASPIRINAarkish Pharmaceuticals NJ Inc.e5e9e1ce-666a-461f-8287-a4642902067c2026-03-23WarningsExact identifier
ndc (package): 81005-103-10
ndc (package): 81005-103-30
ndc (product): 81005-103
ndc11 (package): 81005010330
ndc11 (package): 81005010310
spl id: 4db493f2-2c80-b73e-e063-6394a90ad734
spl set id: e5e9e1ce-666a-461f-8287-a4642902067c

Reported adverse events (FAERS/openFDA)#

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