Adult Aspirin Enteric Coated Tablets, 81 mg

Manufacturer
Cardinal Health, Inc.
Effective date
2016-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:41

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure16 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 or other symptoms needing immediate relief. 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 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 or other symptoms needing immediate relief.

  • 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 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 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

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 have asthma
  • you are taking a diuretic

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 •have bloody or black stools •vomit blood •have stomach pain that does not get better
  • any new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious illness.

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.

OVERDOSAGE SECTION

In case of accidental 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

HOW SUPPLIED SECTION

  • store at room temperature
  • save carton for full directions and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, glyceryl monostearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium bicarbonate, sodium lauryl sulfate, talc, triethyl citrate, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-341-9214

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

carton labelcarton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0105-12020-02-12C16284748780-19d75b9d0-15b5-f424-e053-dadaa90a57ceAdult Aspirin Enteric Coated Tablets, 81 mg
70000-0105-12020-01-31C16284748780-19d75b9d0-15b5-f424-e053-dadaa90a57ceAdult Aspirin Enteric Coated Tablets, 81 mg

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-010570000-0105-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2544c05f-bc27-7121-e054-00144ff88e882544c05f-bc26-7121-e054-00144ff88e882016-07-15WarningsExact identifier
spl id: 2544c05f-bc27-7121-e054-00144ff88e88
spl set id: 2544c05f-bc26-7121-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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