FDA.reportPublic FDA data

ASPIRIN

Manufacturer
SPIRIT PHARMACEUTICALS LLC | Time Cap Laboratories, Inc.
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:25

Label at a glance#

ProductASPIRIN LOW DOSE CHEWABLE
Active ingredientASPIRIN
Label structure11 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever or other symptoms needing immediate relief. ask your doctor about other uses for 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

each tablet contains: sodium 0.22 mg save carton for full directions and warnings store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 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. Because of its delayed action, this product will not provide fast relief of headaches, fever or other symptoms needing immediate relief.
  • ask your doctor about other uses for Aspirin 81 mg

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma(wheezing)
  • shock

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause 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 other)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

OTC - DO NOT USE SECTION

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 0.22 mg
  • save carton for full directions and warnings
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT (Butylated Hydroxytoluene), dextrates, FD&C Yellow#6 Aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sucralose, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

SPIRIT PHARMACEUTICALS, LLC.

RONKONKOMA, NY 11779

PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS™

Compare to the active ingredient in

Bayer® Chewable Low Dose

Aspirin Regimen**

ASPIRIN CHEWABLE

ADULT LOW STRENGTH PAIN RELIEVER

ASPIRIN 81 mg (NSAID)*

36 TABLETS

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN2
318272aspirin 81 MG Chewable TabletSCD2
318272ASA 81 MG Chewable TabletSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-0220-32023-01-30C16284748780-1f386c649-e31a-0266-e053-dadaa90a7c1aVALUMEDS ASPIRIN CHEWABLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0220-3ASPIRINLOW DOSE CHEWABLE36 in 1 BOTTLETABLET, CHEWABLE362
68210-0220-3ASPIRINLOW DOSE CHEWABLE1 in 1 CARTONTABLET, CHEWABLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0220ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SPIRIT PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20191227_eb330933-be20-4c8e-a1aa-64c4f085c279.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-022068210-0220-3

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
DEXTRATESG263MI44RUIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
ORANGE5EVU04N5QUIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
STEARIC ACID4ELV7Z65APIACT
ASPIRINR16CO5Y76EACTIB

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
9aa3946f-4059-482a-e053-2995a90a6072eb330933-be20-4c8e-a1aa-64c4f085c2792019-12-26WarningsExact identifier
spl id: 9aa3946f-4059-482a-e053-2995a90a6072
spl set id: eb330933-be20-4c8e-a1aa-64c4f085c279

Reported adverse events (FAERS/openFDA)#

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