481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS

Manufacturer
Proficient Rx LP
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:22:46

Label at a glance#

ProductLOW DOSE ASPIRIN
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pains 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. 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 of 12 years and over, take 4-8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor Children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever

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 right away.

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains 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.
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 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 bleeding problems

Take a blood thinning (anticoagulant) or steroid drug

Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

Directions

DOSAGE & ADMINISTRATION SECTION

Drink a full glass of water with each dose

Adults and children of 12 years and over, take 4-8 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 Ingredients

INACTIVE INGREDIENT SECTION

Anhydrous lactose, carnuba 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, titanium dioxide, triethyl citrate.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71205-112-30
71205-112-30

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
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
71205-112-00LOW DOSE ASPIRIN100 in 1 BOTTLE, PLASTICTABLET, COATED1008
71205-112-10LOW DOSE ASPIRIN10 in 1 BOTTLE, PLASTICTABLET, COATED108
71205-112-30LOW DOSE ASPIRIN30 in 1 BOTTLE, PLASTICTABLET, COATED308
71205-112-60LOW DOSE ASPIRIN60 in 1 BOTTLE, PLASTICTABLET, COATED608
71205-112-72LOW DOSE ASPIRIN120 in 1 BOTTLE, PLASTICTABLET, COATED1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-112LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [PROFICIENT RX LP]8Current NDC, Legacy NDC, 5 package rows20241006_e839bff7-779a-446d-8486-c0e0a1b6d665.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-112-00EA - Each71205-11264356a77-849e-4a6c-9174-bb768844ccf912024-12-10
71205-112-10EA - Each71205-112b9768c39-d8a7-411a-97f1-469da8a692c612018-11-06
71205-112-30EA - Each71205-112314803bd-62df-4d99-86bf-7ca4928413ae12022-06-06
71205-112-72EA - Each71205-112d9e92573-4671-48ee-92d2-a4f392e5362812021-07-15
49483-481-10EA - Each49483-48168c3b475-b23b-4a98-95f3-b88442ecc38e12017-06-15
49483-481-12EA - Each49483-4816d406952-771a-4b61-979e-0a5c9475bf6112017-06-15

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-11271205-112-10, 71205-112-30, 71205-112-60, 71205-112-00, 71205-112-72
49483-481

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

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
LOW DOSE ASPIRINASPIRINProficient Rx LPe839bff7-779a-446d-8486-c0e0a1b6d6652024-10-01WarningsExact identifier
ndc (package): 71205-112-72
ndc (package): 71205-112-10
ndc (package): 71205-112-00
ndc (package): 71205-112-60
ndc (package): 71205-112-30
ndc (product): 71205-112
ndc11 (package): 71205011260
ndc11 (package): 71205011230
ndc11 (package): 71205011210
ndc11 (package): 71205011272
ndc11 (package): 71205011200
spl id: 6b96f8cf-a830-442f-9d03-3add6bf4ab9c
spl set id: e839bff7-779a-446d-8486-c0e0a1b6d665
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
ndc (product): 49483-481

Reported adverse events (FAERS/openFDA)#

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