FDA.reportPublic FDA data

Low Dose Aspirin

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:17

Label at a glance#

ProductLow Dose Aspirin
Active ingredientASPIRIN
Label structure9 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 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 to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Storage and handling

Tamper Evident: Do not use if safety seal under cap is broken or missing store at room temperature 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

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 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
  • this product 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

  • the 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
  • an allergic reaction occurs. Seek mredical help right away
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-366-11

Manufactured in the USA

Aspirin Regimen

Chewable

Aspirin

Low Dose

81mg Pain Reliever (NSAID)

*Compare to the active ingredient in BAYER® Chewable Aspirin

Orange Flavored

1000 TABLETS 

Talk to your doctor or other healthcare provider before using this product for your heart.

Chewable Aspirin 81mg low Dose Tablet Product Label.jpgChewable Aspirin 81mg low Dose Tablet Product Label.jpg

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-366-052023-06-08C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-112023-06-08C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-052023-01-30C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-112023-01-30C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-052021-03-30C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-112021-03-30C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-052020-01-31C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts
16103-366-112020-01-31C16284748780-19d75b9d0-949c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-366-05Low Dose Aspirin36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE365
16103-366-05Low Dose Aspirin1 in 1 CARTONTABLET, CHEWABLE15
16103-366-11Low Dose Aspirin1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10005

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083G1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

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
16103-36616103-366-05, 16103-366-11

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
DEXTROSE MONOHYDRATELX22YL083GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTROCHE / ORAL4440 mgExact identifier — unii+route
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTROCHE / ORAL4440 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET / ORAL11 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTROCHE / ORAL4440 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GCAPSULE / ORAL345 mgExact identifier — unii+route
15 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GGRANULE, FOR SUSPENSION / ORAL15009 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GGRANULE, FOR SUSPENSION / ORAL15009 mgExact identifier — unii+route
15 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET, EXTENDED RELEASE / ORAL92 mgExact identifier — unii+route
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET / ORAL11 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET, EXTENDED RELEASE / ORAL92 mgExact identifier — unii+route
15 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GCAPSULE / ORAL345 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET, EXTENDED RELEASE / ORAL92 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET / ORAL11 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GGRANULE, FOR SUSPENSION / ORAL15009 mgExact identifier — unii+route
15 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GCAPSULE / ORAL345 mgExact identifier — unii+route
15 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.2763a733-d617-4d95-8429-fbf81d9d77fb2025-12-24WarningsExact identifier
ndc (package): 16103-366-11
ndc (package): 16103-366-05
ndc (product): 16103-366
ndc11 (package): 16103036611
ndc11 (package): 16103036605
spl id: 9031ec5c-852d-4434-8099-e0fc6fa7b92d
spl set id: 2763a733-d617-4d95-8429-fbf81d9d77fb

Reported adverse events (FAERS/openFDA)#

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