Aspirin 81 mg

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:52:55

Label at a glance#

ProductAspirin 81 mg
Active ingredientASPIRIN
Label structure16 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69168-066-02

Reliable-1

Adult Low Strength

Pain Reliever

Aspirin USP 81 mg (NSAID)

Enteric Coated

120 tablets

Compare to Active Ingredient in Aspirin Regimen BAYER®

Rev 01 Reliable-1 Aspirin 81 120 ct front panelRev 01 Reliable-1 Aspirin 81 120 ct front panelRev 01 Reliable-1 Aspirin 81 120 ct back panelRev 01 Reliable-1 Aspirin 81 120 ct back panelRev 01 Reliable-1 Aspirin 81 1000 ct front panelRev 01 Reliable-1 Aspirin 81 1000 ct front panelRev 01 Reliable-1 Aspirin 81 1000 ct back panelRev 01 Reliable-1 Aspirin 81 1000 ct back panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN8
308416aspirin 81 MG Delayed Release Oral TabletSCD8
308416ASA 81 MG Delayed Release Oral TabletSY8
308416aspirin 81 MG Enteric Coated Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
69618-066-022023-03-29C16284748780-1f386c649-d095-0266-e053-dadaa90a7c1aAspirin 81mg EC
69618-066-102023-03-29C16284748780-1f386c649-d095-0266-e053-dadaa90a7c1aAspirin 81mg EC
69618-066-022023-01-30C16284748780-1f386c649-d095-0266-e053-dadaa90a7c1aAspirin 81mg EC
69618-066-102023-01-30C16284748780-1f386c649-d095-0266-e053-dadaa90a7c1aAspirin 81mg EC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-066-02Aspirin 81 mg120 in 1 BOTTLE, PLASTICTABLET, COATED1208
69618-066-10Aspirin 81 mg1000 in 1 BOTTLE, PLASTICTABLET, COATED10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-066ASPIRIN 81 MG (ASPIRIN) TABLET, COATED [RELIABLE 1 LABORATORIES LLC]8Current NDC, Legacy NDC, 2 package rows20250117_b247fe39-7f65-e502-e053-2a95a90a08f1.zip

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
69618-06669618-066-10, 69618-066-02

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
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
ndc (package): 69618-066-02
ndc (package): 69618-066-10
ndc (product): 69618-066
ndc11 (package): 69618006610
ndc11 (package): 69618006602
spl id: 2bc86823-a7dc-875d-e063-6394a90a992a
spl set id: b247fe39-7f65-e502-e053-2a95a90a08f1

Reported adverse events (FAERS/openFDA)#

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