aspirin

Manufacturer
Time-Cap Labs, Inc
Effective date
2018-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:43

Label at a glance#

Productaspirin low dose enteric coated
Active ingredientASPIRIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever

*nonsteroidal anti-inflammatory drug

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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

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

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

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 - 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 - 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 because it may cause problems in the unborn child or

complications during delivery.

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.

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.

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

Warnings

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
shock
asthma (wheezing)

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
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF BULK LABELIMAGE OF BULK LABELEnter section text here

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-390-00aspirinlow dose enteric coated100000 in 1 CARTONTABLET1000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-390ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET [TIME-CAP LABS, INC]2Current NDC, Legacy NDC, 1 package rows20181218_7146c505-2469-4bc2-9e1e-ceb60951c8ae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76E1
aspirinACTIVE MOIETYR16CO5Y76E1

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
49483-39049483-390-00

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc7146c505-2469-4bc2-9e1e-ceb60951c8ae2018-12-17WarningsExact identifier
ndc (package): 49483-390-00
ndc (product): 49483-390
ndc11 (package): 49483039000
spl id: 7d3f7c1d-79ea-acce-e053-2a91aa0acd38
spl set id: 7146c505-2469-4bc2-9e1e-ceb60951c8ae

Reported adverse events (FAERS/openFDA)#

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