Aspirin USP 81 mg Enteric Coated Tablet

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2015-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:28:08

Label at a glance#

ProductAspirin 81 mg Enteric Coated
Active ingredientASPIRIN
Label structure18 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 you doctor because serious side effects may occur.

Dosage and administration

DRINK A FULL GLASS OF WATER WITH EACH DOSE adults and children 12 years & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin USP, 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

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 you doctor because serious side effects may occur.

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 comiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

OTHER SAFETY INFORMATION

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 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 steriod drug
  • take other drugs containing prescription or non-prescription NSAIDs (ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Drug Facts continued on back of label

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 diabetes, gout or arthritis
  • under a doctor's care for any s

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 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 ear or loss of hearing occurs

these could be sings of a serious condition

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 complictions 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 & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow #10 (Al-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, corn strach, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-017-02

Enteric Coated

Aspirin USP 81 mg (NSAID)

Adult Low Strength

PAIN RELIEVER

120 TABLETS

*Compare to Active Ingredient in Aspirin Regimen BAYER®

ASPIRIN 81 MG EC TABLET - 120ASPIRIN 81 MG EC TABLET - 120

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-017-02EA - Each69618-0171439a157-4d9b-4fd2-bb57-ef15f737144412016-03-04
69618-017-10EA - Each69618-0179be5e077-0a55-41d2-9fa2-46188af48c9c12016-03-04

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-01769618-017-02, 69618-017-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
c927a1d1-504e-9c42-e053-2a95a90ad4952c75dadc-a7d3-0b6a-e054-00144ff8d46c2021-08-09WarningsExact identifier
spl set id: 2c75dadc-a7d3-0b6a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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