Low Dose Aspirin

Manufacturer
Akron Phama
Effective date
2025-07-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:06:38

Label at a glance#

ProductLow Dose Aspirin
Active ingredientASPIRIN
Label structure14 sections

Storage and handling

Other information store at room temperature 15 º -30 º C(59 º -86 º F) read all product information before using

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose   Pain reliever

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

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 the symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:  Asiprin 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.  Ths 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 of nonprescription NSAIDS [aspirin, ibuprofin, 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

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 that 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 signs of a serious condition.          

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.

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.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 while symptoms last
  • do not take more than 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years:  ask a doctor

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow#10 al lake, FD&C yellow#6 al lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions or comments?  Call toll-free 1-877-225-6999

Monday to Friday 9AM to 5PM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN4
308416aspirin 81 MG Delayed Release Oral TabletSCD4
308416ASA 81 MG Delayed Release Oral TabletSY4
308416aspirin 81 MG Enteric Coated Oral TabletSY4

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8627-1Low Dose Aspirin1000 in 1 BOTTLETABLET, COATED10004
71399-8627-2Low Dose Aspirin120 in 1 BOTTLETABLET, COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8627-1EA - Each71399-8627f3306955-787e-4644-b4a5-8b9fa03792e012021-07-15
71399-8627-2EA - Each71399-862711779293-9607-4ff1-b4d8-7f27c6bf3d8e12021-07-15

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-862771399-8627-1, 71399-8627-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
7c67ef4d-3d10-44bb-9cc4-f270c92ef537cfe9dc65-dfbb-4c36-a8c9-57bb460a8d972025-07-07WarningsExact identifier
spl id: 7c67ef4d-3d10-44bb-9cc4-f270c92ef537
spl set id: cfe9dc65-dfbb-4c36-a8c9-57bb460a8d97

Reported adverse events (FAERS/openFDA)#

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