Aspirin 81mg EC

Manufacturer
HAWAII REPACK, INC.
Effective date
2026-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-01 13:01:52

Label at a glance#

ProductAspirin 81 mg
Active ingredientASPIRIN
Label structure17 sections

Indications and uses

temporarily relieves minor aches and pains Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 81 mg 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains

Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

Warnings

WARNINGS SECTION

Reye's syndrome:Children and teenagers who have or are recoving 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 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

- shock

- asthma (wheezing)

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 contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)

- have 3 or more alcoholic drinks every day while using this product

- take more or for longer time than directed

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

- taking a prescription drug for diabetes, gout, or arthritis

- taking any other drug

- under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

-an allergic reaction occurs. Seek medical help right away.

- you are experierance 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

- 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.

these could be signs 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 becwause 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

- store at 25°C (77°F) excursions premitted between 15°-30°C (59°-86°F)

- Use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.

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

you have not been drinking fluids

you have lost a lot of fluid due to vomiting or diarrhea

SPL UNCLASSIFIED SECTION

Distributed by:
Hawaii Repack, Inc.
677 Ala Moana Blvd Ste 700,
Honolulu, Hawaii-96813

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-066-02EA - Each69618-06662b9ed73-35e0-48f9-8353-be8d0065dad012021-06-02
69618-066-10EA - Each69618-066ed5bac14-7d3d-4c3b-942e-399a7565711512021-06-02

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
85534-004285534-0042-0, 85534-0042-1, 85534-0042-2, 85534-0042-3
69618-066

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-07-17daily-update2026-07-21 05:10:18

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
ndc (package): 85534-0042-3
ndc (package): 85534-0042-1
ndc (package): 85534-0042-2
ndc (package): 85534-0042-0
ndc (product): 85534-0042
ndc11 (package): 85534004201
ndc11 (package): 85534004202
ndc11 (package): 85534004203
ndc11 (package): 85534004200
spl id: 5a14c6a7-a60c-f811-e063-6294a90a1213
spl set id: ac94cce3-9a39-41de-bb8b-10a5e5b8e83b
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
ndc (product): 69618-066

Reported adverse events (FAERS/openFDA)#

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