Aspirin USP 81 mg Chewable Tablets

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2023-03-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:54:36

Label at a glance#

ProductAspirin 81 mg
Active ingredientASPIRIN
Label structure19 sections

Indications and uses

temporarily relieaves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Dosage and administration

DRINK A FULL GLASS OF WATER WITH EACH DOSE adults and children 12 years & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

Store at room temperature 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin USP 81 mg (NSAID)*

*nonsterodial anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieaves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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

SPL UNCLASSIFIED SECTION

Allergy alert: Aspirin may cause a severe allergic reastion which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSID, 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 containing prescription or non-prescription NSAIDs (ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

Drug Facts continued on back of label

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery

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

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
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Incase 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 & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
  • children under 12 years: ask a doctor

Other infomation

STORAGE AND HANDLING SECTION

  • Store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, corn starch, FD&C yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BAYER®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-014-36

ORANGE FLAVORED

Aspirin USP 81 mg (NSAID)

Adult Low Strength

PAIN RELIEVER

36 CHEWABLE TABLETS

*Compare to Active Ingredient in Aspirin Regimen BAYER® Chewable

Aspirin 81 mg chewAspirin 81 mg chew

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN5
318272aspirin 81 MG Chewable TabletSCD5
318272ASA 81 MG Chewable TabletSY5

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
69618-014-36Aspirin 81 mg36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-014ASPIRIN 81 MG (ASPIRIN) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC]5Legacy NDC, 1 package rows20230331_2cec3d3d-21d9-476c-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-014-36EA - Each69618-014de81857a-c103-4673-b639-b7386dfc9db712016-04-04

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-01469618-014-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
f811e96c-0896-d200-e053-6294a90a588d2cec3d3d-21d9-476c-e054-00144ff88e882023-03-29WarningsExact identifier
spl id: f811e96c-0896-d200-e053-6294a90a588d
spl set id: 2cec3d3d-21d9-476c-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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