FDA.reportPublic FDA data

Chewable Aspirin

Manufacturer
Grocery Outlet
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:02

Label at a glance#

ProductChewable Aspirin Low Dose
Active ingredientASPIRIN
Label structure9 sections

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

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Use(s)

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pains or as recommended by your doctor

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: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock.

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

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by
    a doctor
  • if you have ever had an allergic reaction to this product or any of its
    ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor before use if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away
  • 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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs 

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially
important not to use aspirin during the last 3 months of pregnancy unless
specifically 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

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Other information

SPL UNCLASSIFIED SECTION

store at room temperature.

DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

RETAIN CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-877-290-4008

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelCartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN1
318272aspirin 81 MG Chewable TabletSCD1
318272ASA 81 MG Chewable 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-130810159835572GTIN-13: 0810159835572
EAN-13: 0810159835572
GTIN-12: 810159835572
UPC-A: 810159835572
GTIN storage (14 digits): 00810159835572		chewable-aspirin-2.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
85828-288-36Chewable AspirinLow Dose36 in 1 BOTTLETABLET, CHEWABLE361
85828-288-36Chewable AspirinLow Dose3 in 1 CARTONTABLET, CHEWABLE31

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
85828-28885828-288-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
DEXTRATESG263MI44RUIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
Chewable Aspirin Low DoseCHEWABLE ASPIRINGrocery Outlet609c0389-8bed-4483-84fa-73ee73fdb4e42026-03-20WarningsExact identifier
ndc (package): 85828-288-36
ndc (product): 85828-288
ndc11 (package): 85828028836
spl id: 2aba1fe1-5ed8-4daa-8f23-013a9335377b
spl set id: 609c0389-8bed-4483-84fa-73ee73fdb4e4

Reported adverse events (FAERS/openFDA)#

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