FDA.reportPublic FDA data

Aspirin Low Dose Chewable Orange

Manufacturer
MAJOR PHARMACEUTICALS | Pharbest Pharmaceuticals, Inc.
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:49:14

Label at a glance#

ProductAspirin Low Dose Chewable Orange
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommneded by your doctor ask your doctor about other uses for Chewable Aspirin 81 mg

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 exceed 48 tablets in 24 hours unless directed by a doctor  children under 12 years  consult a doctor

Storage and handling

store at room temperature (15 0 -30 0 C) Tamper Evident:  do not use if safety seal under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains or as recommneded by your doctor
  • ask your doctor about other uses for Chewable Aspirin 81 mg

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
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are 

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor 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
  • fever get worse or lasts more than 3 days
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding

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 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

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

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 exceed 48 tablets in 24 hours unless directed by a doctor
 children under 12 years consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature (150-300C)
  • Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Bayer®Chewable Aspirin**

NDC 0904-6794-80

ASPIRIN

LOW DOSE

CHEWABLE

ORANGE

PAIN RELIEVER

(NSAID)

81mg

1000 TABLETS

image of Major Aspirin 81 mg Chewable Tablet Product Labelimage of Major Aspirin 81 mg Chewable Tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN7
318272aspirin 81 MG Chewable TabletSCD7
318272ASA 81 MG Chewable TabletSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0904-6794-30Aspirin Low Dose Chewable Orange300 in 1 CARTONTABLET, CHEWABLE3007
0904-6794-30Aspirin Low Dose Chewable Orange1 in 1 BLISTER PACKTABLET, CHEWABLE17
0904-6794-80Aspirin Low Dose Chewable Orange1000 in 1 PACKAGETABLET, CHEWABLE10007
0904-6794-89Aspirin Low Dose Chewable Orange90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6794-30EA - Each0904-67940b6b3501-8a59-4d48-864f-25efe4b4475912023-04-07
0904-6794-80EA - Each0904-679478376407-1c58-42be-9458-6e0c6219806812018-11-06
0904-6794-89EA - Each0904-6794b50d3dc8-f0d6-49f7-ac05-baa38562ec1d12018-11-06

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-67940904-6794-89, 0904-6794-80, 0904-6794-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DEXTROSE MONOHYDRATELX22YL083GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-12-19monthly-update2026-06-03 17:46:28

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 Dose Chewable OrangeASPIRINMAJOR PHARMACEUTICALSfb3a8e38-e991-49c9-93dc-1d29c0a97ba32026-03-05WarningsExact identifier
ndc (package): 0904-6794-89
ndc (package): 0904-6794-80
ndc (package): 0904-6794-30
ndc (product): 0904-6794
ndc11 (package): 00904679480
ndc11 (package): 00904679489
ndc11 (package): 00904679430
spl id: f2922418-7d2c-4a41-b28a-41769521b297
spl set id: fb3a8e38-e991-49c9-93dc-1d29c0a97ba3

Reported adverse events (FAERS/openFDA)#

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