ASPIRIN LOW DOSE

Manufacturer
AARNA USA INC.
Effective date
2025-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:08

Label at a glance#

ProductASPIRIN LOW DOSE
Active ingredientASPIRIN
Label structure14 sections

Storage and handling

Other information store at room temperature 20 º-25 ºC(68 º-77 ºF) read all product information before using TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing.

Label contents#

Full prescribing information#

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 20 º-25 ºC(68 º-77 ºF)
  • read all product information before using
  • TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

colloidal silicon dioxide, crospovidone, D&C yellow #10 lake, hydroxypropyl methyl cellulose,methacrylic acid copolymer,microcrystalline cellulose, starch maize,starch pregelatinized, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

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

Monday to Friday 9AM to 5PM

*This product is not manufactured or distributed by Bayer Health Care LLC., owner of the registered Bayer® Low Dose Aspirin.

Manufactured for:

Aarna USA Inc.

Leland, NC 28451

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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

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
82568-0003-1ASPIRIN LOW DOSE120 in 1 BOTTLETABLET1201
82568-0003-2ASPIRIN LOW DOSE1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0003ASPIRIN LOW DOSE TABLET [AARNA USA INC.]1Current NDC, 2 package rows20250519_347edc8f-6391-b75e-e063-6394a90a1cf5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0003-1EA - Each82568-000350678e63-75ae-4e80-9308-ecfbd641c96412025-11-13
82568-0003-2EA - Each82568-00038ae16ca3-279e-4078-b72b-bc63fa19396312025-11-13

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82568-000382568-0003-2, 82568-0003-1

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 LOW DOSEASPIRIN LOW DOSEAARNA USA INC.347edc8f-6391-b75e-e063-6394a90a1cf52025-05-06WarningsExact identifier
ndc (package): 82568-0003-2
ndc (package): 82568-0003-1
ndc (product): 82568-0003
ndc11 (package): 82568000302
ndc11 (package): 82568000301
spl id: 347edc8f-6392-b75e-e063-6394a90a1cf5
spl set id: 347edc8f-6391-b75e-e063-6394a90a1cf5

Reported adverse events (FAERS/openFDA)#

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