FDA.reportPublic FDA data

Chewable Low Dose Aspirin

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | TIME CAP LABORATORIES, INC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:56

Label at a glance#

ProductChewable Low 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 81 mg Orange chewable aspirin

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 chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (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 81 mg Orange chewable aspirin

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 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 gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a 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 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

OTHER SAFETY INFORMATION

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, dextrates, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, modified corn starch, pregelatinized starch, sodium saccharin, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

334R-Target-Low dose Aspirin 81 mg-108s-label334R-Target-Low dose Aspirin 81 mg-108s-label334R-Target-Low dose Aspirin 81 mg-108s-IFC334R-Target-Low dose Aspirin 81 mg-108s-IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN3
318272aspirin 81 MG Chewable TabletSCD3
318272ASA 81 MG Chewable TabletSY3

DailyMed Pharmacologic Classes#

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

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
11673-493-19Chewable Low Dose Aspirin3 in 1 CARTONTABLET, CHEWABLE33
11673-493-63Chewable Low Dose Aspirin36 in 1 BOTTLETABLET, CHEWABLE363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-493CHEWABLE LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [TARGET CORPORATION]3Current NDC, 2 package rows20250117_f934e72a-2e9f-da17-e053-6394a90a1a2e.zip

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
11673-49311673-493-63, 11673-493-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ASPIRINR16CO5Y76EACTIB
DEXTRATESG263MI44RUIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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 Low Dose AspirinASPIRINTARGET CORPORATIONf934e72a-2e9f-da17-e053-6394a90a1a2e2025-01-15WarningsExact identifier
ndc (package): 11673-493-19
ndc (package): 11673-493-63
ndc (product): 11673-493
ndc11 (package): 11673049363
ndc11 (package): 11673049319
spl id: 2bbc691d-69ec-f99c-e063-6394a90a8c08
spl set id: f934e72a-2e9f-da17-e053-6394a90a1a2e

Reported adverse events (FAERS/openFDA)#

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