Adult Aspirin Orange Flavored Chewable Tablets, 81 mg

Manufacturer
Cardinal Health, Inc.
Effective date
2017-03-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:17:57

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 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
  • 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
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have had stomach ulcers or bleeding problems
  • 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
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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

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

  • 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 medical help right away.
  • any new symptoms occur
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present

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 pt contact a Poison Control Center right away (1-800-222-1222).

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

HOW SUPPLIED SECTION

  • store at room temperature
  • avoid excess heat and moisture

Inactive ingredient

INACTIVE INGREDIENT SECTION

dextrose anhydrous, FD&C yellow #6 aluminum lake, microcrystalline cellulose, mint flavor, orange flavor, pregelatinized starch, saccharin sodium, talc.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-341-9214

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

36ct bottle label36ct bottle label

36ct carton label36ct carton label

value pack bottlevalue pack bottlevalue pack cartonvalue pack carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0103-1EA - Each70000-0103e40403e9-861c-4870-901a-dba437bfcd7012017-12-14
70000-0103-3EA - Each70000-010308daac15-81ce-4e3c-b6dc-0a9c965f37fb12018-03-08

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-010370000-0103-1, 70000-0103-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
49bccd33-b46c-49f9-e054-00144ff88e88256a1223-4e1e-49c6-e054-00144ff8d46c2017-03-02WarningsExact identifier
spl id: 49bccd33-b46c-49f9-e054-00144ff88e88
spl set id: 256a1223-4e1e-49c6-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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