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

Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:12:04

Label at a glance#

ProductLOW DOSE ASPIRIN
Active ingredientASPIRIN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Pain reliever

INDICATIONS & USAGE SECTION

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

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
  • 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

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for: ­

  • diabetes ­
  • gout ­
  • arthritis

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

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.

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.

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

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • avoid excessive heat above 40°C (104°F)

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 and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions? Call 1-877-290-4008

HOW SUPPLIED

How Supplied Section

NDC: 71335-1382-8: 15 Tablets in a BOTTLE

NDC: 71335-1382-1: 120 Tablets in a BOTTLE

NDC: 71335-1382-2: 30 Tablets in a BOTTLE

NDC: 71335-1382-3: 100 Tablets in a BOTTLE

NDC: 71335-1382-4: 20 Tablets in a BOTTLE

NDC: 71335-1382-5: 90 Tablets in a BOTTLE

NDC: 71335-1382-6: 60 Tablets in a BOTTLE

NDC: 71335-1382-7: 36 Tablets in a BOTTLE

NDC: 71335-1382-9: 10 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 81 mg EC Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN5
308416aspirin 81 MG Delayed Release Oral TabletSCD5
308416ASA 81 MG Delayed Release Oral TabletSY5
308416aspirin 81 MG Enteric Coated Oral TabletSY5

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
71335-1382-1LOW DOSE ASPIRIN120 in 1 BOTTLETABLET, COATED1205
71335-1382-2LOW DOSE ASPIRIN30 in 1 BOTTLETABLET, COATED305
71335-1382-3LOW DOSE ASPIRIN100 in 1 BOTTLETABLET, COATED1005
71335-1382-4LOW DOSE ASPIRIN20 in 1 BOTTLETABLET, COATED205
71335-1382-5LOW DOSE ASPIRIN90 in 1 BOTTLETABLET, COATED905
71335-1382-6LOW DOSE ASPIRIN60 in 1 BOTTLETABLET, COATED605
71335-1382-7LOW DOSE ASPIRIN36 in 1 BOTTLETABLET, COATED365
71335-1382-8LOW DOSE ASPIRIN15 in 1 BOTTLETABLET, COATED155
71335-1382-9LOW DOSE ASPIRIN10 in 1 BOTTLETABLET, COATED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1382LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20240507_a272bf44-54df-448a-8bff-e31f9488b416.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1382-2EA - Each71335-138260bcd795-8c37-4aa2-ae53-ac8a3508219812021-03-02
71335-1382-3EA - Each71335-1382c43a24a3-2686-436c-86c6-d5155bcbc9c512025-11-13
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 · 18 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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 ASPIRINASPIRINBryant Ranch Prepacka272bf44-54df-448a-8bff-e31f9488b4162024-05-06WarningsExact identifier
ndc (package): 71335-1382-5
ndc (package): 71335-1382-3
ndc (package): 71335-1382-2
ndc (package): 71335-1382-7
ndc (package): 71335-1382-8
ndc (package): 71335-1382-4
ndc (package): 71335-1382-1
ndc (package): 71335-1382-9
ndc (package): 71335-1382-6
ndc (product): 71335-1382
ndc11 (package): 71335138204
ndc11 (package): 71335138206
ndc11 (package): 71335138207
ndc11 (package): 71335138202
ndc11 (package): 71335138201
ndc11 (package): 71335138208
ndc11 (package): 71335138203
ndc11 (package): 71335138209
ndc11 (package): 71335138205
spl id: bc4654ca-a310-4862-bb6f-c56b34f3a86e
spl set id: a272bf44-54df-448a-8bff-e31f9488b416
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.