aspirin

Manufacturer
Major Pharmaceuticals
Effective date
2019-12-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:52:26

Label at a glance#

Productaspirin
Active ingredientASPIRIN
Label structure17 sections

Indications and uses

temporarily relieves 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 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 INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

temporarily relieves 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience the following signs of stomach bleeding: • feel faint
• have bloody or black stools • vomit blood
• 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 a loss of hearing occurs

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 • you
have not been drinking fluids • you have lost a lot of
fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug

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, shock, facial swelling, asthma (wheezing)

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 nonprescritpion 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

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

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 THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º-86ºF)

use by expiration date on package

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 In case of overdose, get medical help or contact Poison Control Center right away

Inactive Ingredients

INACTIVE INGREDIENT SECTION

 BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelantinized starch, sodium saccharin, stearic acid

Purpose

OTC - PURPOSE SECTION

 temporarily relieves minor aches and pains

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

90 Tablets

Page 1 bottle labe
Page 1 bottle labe

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Part 2 of Label

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

90 TabletsLabel Part 2Label Part 2

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Part 3 of Label

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

90 Tablets

Label Part 3
Label Part 3

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin Tablets USP

(Chewable)

Low Dose

81 mg

1000 tablets

bottle label
bottle label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6288-80EA - Each0904-62886764713c-a888-4e9e-8a26-cee1e735d28e12017-11-06
0904-6288-89EA - Each0904-6288ed0a1686-0d72-4f58-aa21-42429910a98312012-07-24
49483-334-63EA - Each49483-33410867ed2-4d3a-4fcb-9e26-5b270e6ceb6c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E3
ASPIRINACTIVE MOIETYR16CO5Y76E3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
DEXTRATESINACTIVE INGREDIENTG263MI44RU3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A83
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6T3
ORANGEINACTIVE INGREDIENT5EVU04N5QU3
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP3

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-62880904-6288-89, 0904-6288-80
49483-334

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii+route
10 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii+route
2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii+route
10 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TSUSPENSION / ORAL920 mgExact identifier — unii+route
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii+route
10 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii+route
10 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin low dose chewableASPIRINTime-Cap Labs, Inc5d56618c-8ea2-42ea-a9f2-339bd0055ddd2024-04-17WarningsExact identifier
ndc (product): 49483-334
3a37ed91-53c0-46c5-a014-7e1612ac7edf708fdd83-c749-420d-b3e2-4e52d9f5d57f2019-12-10WarningsExact identifier
spl id: 3a37ed91-53c0-46c5-a014-7e1612ac7edf
spl set id: 708fdd83-c749-420d-b3e2-4e52d9f5d57f

Reported adverse events (FAERS/openFDA)#

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