FDA.reportPublic FDA data

ASPIRIN

Manufacturer
Allegiant Health
Effective date
2018-11-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:00

Label at a glance#

ProductASPIRIN Enteric Coated
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pain 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.

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 of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pain 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.

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
  • facial swelling
  • asthma (wheezing)
  • shock

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 non presecription 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

Do not use

OTC - DO NOT USE SECTION

if you are allergic to aspirin or other pain reliever/fever reducer

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking a prescription drug for
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report serious side effects to 1-888-952-0050

Pregnancy/Breastfeeding

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

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 (1-800-222-1222) 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 of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • save carton for full directions and warnings
  • store at room temperature
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bio Formula

ASPIRIN

(NSAID*)

81mg SAFETY COATED

ENTERIC COATED

LOW STRENGTH ASPIRIN REGIMEN

DELAYED RELEASE ASPIRIN

Bio Formula Aspirin 81mg Carton 100ct
Bio Formula Aspirin 81mg Carton 100ct
Bio Formula Aspirin 81mg Label 100ct
Bio Formula Aspirin 81mg Label 100ct
Bio Formula Aspirin 81mg Label 300ct
Bio Formula Aspirin 81mg Label 300ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN6
308416aspirin 81 MG Delayed Release Oral TabletSCD6
308416ASA 81 MG Delayed Release Oral TabletSY6
308416aspirin 81 MG Enteric Coated Oral TabletSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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
69168-318-012023-10-19C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-032023-10-19C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-012023-01-30C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-032023-01-30C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-012020-12-03C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-032020-12-03C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-012020-01-31C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg
69168-318-032020-01-31C16284748780-19d75b9d0-e85a-f424-e053-dadaa90a57ceBio Formula Aspirin 81mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-318-01ASPIRINEnteric Coated1 in 1 CARTONTABLET16
69168-318-01ASPIRINEnteric Coated100 in 1 BOTTLETABLET1006
69168-318-03ASPIRINEnteric Coated300 in 1 BOTTLETABLET3006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-318ASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 3 package rows20231020_5910a882-eb40-440f-8a30-c21fbce9050e.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-31869168-318-01, 69168-318-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
METHACRYLIC ACID1CS02G8656IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
ndc (package): 69168-318-03
ndc (package): 69168-318-01
ndc (product): 69168-318
ndc11 (package): 69168031803
ndc11 (package): 69168031801
spl id: 2899105f-ce56-4f8f-8966-0f18aed41d75
spl set id: 5910a882-eb40-440f-8a30-c21fbce9050e
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
ndc (product): 69168-318

Reported adverse events (FAERS/openFDA)#

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