aspirin low dose enteric coated - A-S Medication Solutions

Manufacturer
A-S Medication Solutions
Effective date
2018-09-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:02:10

Label at a glance#

Productaspirin low dose enteric coated
Active ingredientASPIRIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

OTC - ASK DOCTOR SECTION

Ask a doctor before use if: stomach bleeding waring 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, hou have lost a lot of fluid due to vomiting or diarhea

INDICATIONS & USAGE SECTION

Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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 reactino which may include: hives, facial swelling, shock, asthma(wheezingStomach bleeding warning:  This product contains an NSAID which may cause severe stomach bleeding.  The chance is higher if you: are age 60 or older, hae had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non prescription 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.

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 serious condition; taking any other drug

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if: you experience 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, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health profession 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:  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

INACTIVE INGREDIENT SECTION


Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, itianium dioxide

OTC - PURPOSE SECTION

Uses - temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2832

NDC: 50090-2832-0 1 TABLET, COATED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE

aspirin

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 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
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
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
50090-2832-02020-01-31C16284748780-19d75b9d0-3823-f424-e053-dadaa90a57cef4743dca-8d91-4811-b229-5b6cb38cc884

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2832-0aspirinlow dose enteric coated33 in 1 BOX, UNIT-DOSETABLET, COATED336
50090-2832-0aspirinlow dose enteric coated1 in 1 BLISTER PACKTABLET, COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2832ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20190225_f4743dca-8d91-4811-b229-5b6cb38cc884.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2832-0EA - Each50090-2832756cdfbf-6350-4619-b8f7-b3ea49412bbf12018-11-06
49483-387-00EA - Each49483-3873f67641d-ded2-4398-a7c8-755c11baeb6a12022-06-06
49483-387-12EA - Each49483-387d030cc62-0ae3-4f8e-b43a-cd027d175db012012-07-24

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-283250090-2832-0
49483-387

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc5aaf8b66-b00e-4bc8-972c-bbe6825284fb2018-12-17WarningsExact identifier
ndc (product): 49483-387
3bf6a59a-b2f6-4914-8886-2f23412e1012f4743dca-8d91-4811-b229-5b6cb38cc8842018-09-21WarningsExact identifier
spl id: 3bf6a59a-b2f6-4914-8886-2f23412e1012
spl set id: f4743dca-8d91-4811-b229-5b6cb38cc884

Reported adverse events (FAERS/openFDA)#

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