ASPIRIN 81mg Chewable Tablets

Manufacturer
PHARMAMED USA INC
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:44:03

Label at a glance#

ProductPain Reliever / Low Dose Aspirin
Active ingredientASPIRIN
Label structure15 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommended by your doctor ask your doctor about other uses for this product

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 (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 recommended by your doctor
  • ask your doctor about other uses for this product

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 alergic 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 alergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsilectomy or oral surgery unless directed by a doctor
  • if you have 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 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

  • 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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 (1-800-222-1222).

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

Other information

OTHER SAFETY INFORMATION

  • Tamper Evident: Do not use if the safety seal under the cap is broken or missing
  • Store at room temperature (15°-30°C) 59ºF- 86ºF
  • Avoid excess heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn starch, dextrose monohydrate, FD&C yelow #6, flavor, silicon dioxide, sodium saccharine and stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756 (Mon-Fri 8AM to 4PM EST)

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMAMED

NDC 84289-366-36

Manufactured in the U.S.A

Pain Reliever (NSAID) / Low Dose

ASPIRIN

Aspirin 81 mg

36 CHEWABLE

Aspirin regimen

Orange Flavored

*Compare to the active ingredient in BAYER Chewable Aspirin

FRONTFRONTBACKBACK

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860011951209GTIN-13: 0860011951209
EAN-13: 0860011951209
GTIN-12: 860011951209
UPC-A: 860011951209
GTIN storage (14 digits): 00860011951209
FRONT 2026 Label ASPIRIN CHEWABLE LABEL - Pharmamed_page-0001.jpg

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
84289-366-36Pain Reliever / Low Dose Aspirin36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE365

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-366-05EA - Each16103-36643e318c1-7d8b-4f10-84ab-569525198cf912013-05-02
16103-366-11EA - Each16103-3662d57c73f-13ee-45d4-ba9d-0539d67d4a8612013-05-02

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
84289-36684289-366-36
16103-366

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever / Low Dose AspirinASPIRINPHARMAMED USA INC1a3ff0da-85eb-542c-e063-6294a90a9cca2026-02-12WarningsExact identifier
ndc (package): 84289-366-36
ndc (product): 84289-366
ndc11 (package): 84289036636
spl id: 4aa69fbd-12a9-5078-e063-6294a90aade7
spl set id: 1a3ff0da-85eb-542c-e063-6294a90a9cca
Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.2763a733-d617-4d95-8429-fbf81d9d77fb2025-12-24WarningsExact identifier
ndc (product): 16103-366

Reported adverse events (FAERS/openFDA)#

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