Adult Low Dose Enteric Coated Aspirin

Manufacturer
TYA Pharmaceuticals
Effective date
2012-08-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:40:46

Label at a glance#

ProductAdult Low Dose Enteric Coated Aspirin
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pains ask your doctor about other uses for aspirin

Dosage and administration

drink a full glass of water with each dose swallow whole, do not chew or crush do not exceed recommended dose adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor children under 12 years: ask a doctor

Storage and handling

store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F) for institutional use only

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
  • ask your doctor about other uses for aspirin

Warnings

WARNINGS SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: 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.

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. Reye's Syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy Alert:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Stomach bleeding warning:
  • 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 nonprescription 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

if your are allergic to aspirin or any other pain reliever/fever reducer. Do not use

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

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
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose , get medical help or contact a Poison Control Center right away. Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN2
308416aspirin 81 MG Delayed Release Oral TabletSCD2
308416ASA 81 MG Delayed Release Oral TabletSY2
308416aspirin 81 MG Enteric Coated Oral TabletSY2

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
64725-0981-12020-01-31C16284748780-19d75b9d0-e944-f424-e053-dadaa90a57ce95c34d67-3a72-49d4-89aa-7186ac58c0dc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0981-1Adult Low Dose Enteric Coated Aspirin100 in 1 BOTTLETABLET, COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0981ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_95c34d67-3a72-49d4-89aa-7186ac58c0dc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
ASPIRINACTIVE MOIETYR16CO5Y76E2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G86562
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SHELLACINACTIVE INGREDIENT46N107B71O2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TRIACETININACTIVE INGREDIENTXHX3C3X6732
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64725-098164725-0981-1
50844-600

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET, DELAYED RELEASE / ORAL120 mgExact identifier — unii+route+dosage form
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, DELAYED RELEASE / ORAL199 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route+dosage form
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii+route+dosage form
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii+route+dosage form
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii+route+dosage form
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route+dosage form
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
TRIACETINTRIACETINXHX3C3X673TABLET, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route
3 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, DELAYED RELEASE / ORAL8 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii+route+dosage form
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, EXTENDED RELEASE / ORAL22 mgExact identifier — unii+route
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route+dosage form

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 Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
ndc (product): 50844-600
1fcb1187-31a2-413d-9edd-85bcd07aacec95c34d67-3a72-49d4-89aa-7186ac58c0dc2012-08-22WarningsExact identifier
spl id: 1fcb1187-31a2-413d-9edd-85bcd07aacec
spl set id: 95c34d67-3a72-49d4-89aa-7186ac58c0dc

Reported adverse events (FAERS/openFDA)#

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