Aspirin

Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:57

Label at a glance#

ProductAspirin Low Dose
Active ingredientASPIRIN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not exceed recommended dose drink a full glass of water with each dose swallow whole, do not chew or crush 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 : ask a doctor

Storage and handling

store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)

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

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
  • asthma (wheezing)
  • shock

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

Do not use

  • if your are allergic to aspirin or any other pain reliever/fever reducer.
  • if you ever hadan allergic reaction to this product or any of its ingredients

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 a prescription drug for diabetes, gout or arthritis

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 -vomit blood -have bloody or black stools -have stomach pain that does not get better
  • 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

These can be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • 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: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose,D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, PEG, polydextrose, silica, simethicone, sodium
bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

HOW SUPPLIED

How Supplied Section

Aspirin 81 mg EC Tablets

  • NDC: 71335-0622-1: 120 Tablets in a BOTTLE
  • NDC: 71335-0622-2: 30 Tablets in a BOTTLE
  • NDC: 71335-0622-3: 100 Tablets in a BOTTLE
  • NDC: 71335-0622-4: 20 Tablets in a BOTTLE
  • NDC: 71335-0622-5: 90 Tablets in a BOTTLE
  • NDC: 71335-0622-6: 60 Tablets in a BOTTLE
  • NDC: 71335-0622-7: 36 Tablets in a BOTTLE
  • NDC: 71335-0622-8: 15 Tablets in a BOTTLE
  • NDC: 71335-0622-9: 10 Tablets in a BOTTLE

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 81 mg EC Tablets

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN4
308416aspirin 81 MG Delayed Release Oral TabletSCD4
308416ASA 81 MG Delayed Release Oral TabletSY4
308416aspirin 81 MG Enteric Coated Oral TabletSY4

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0622-1AspirinLow Dose120 in 1 BOTTLETABLET, COATED1204
71335-0622-2AspirinLow Dose30 in 1 BOTTLETABLET, COATED304
71335-0622-3AspirinLow Dose100 in 1 BOTTLETABLET, COATED1004
71335-0622-4AspirinLow Dose20 in 1 BOTTLETABLET, COATED204
71335-0622-5AspirinLow Dose90 in 1 BOTTLETABLET, COATED904
71335-0622-6AspirinLow Dose60 in 1 BOTTLETABLET, COATED604
71335-0622-7AspirinLow Dose36 in 1 BOTTLETABLET, COATED364
71335-0622-8AspirinLow Dose15 in 1 BOTTLETABLET, COATED154
71335-0622-9AspirinLow Dose10 in 1 BOTTLETABLET, COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0622ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 9 package rows20240725_61ecf3c9-42fa-4ae4-bd3b-694090477b9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0622-1EA - Each71335-06225638c74e-83e9-47e1-82c9-68ca7c790cf012018-10-11
71335-0622-2EA - Each71335-0622ce58ec35-3e41-417d-9bfd-aa4b7651003712018-10-11
71335-0622-3EA - Each71335-06226ef2f437-13f3-4108-9ead-9f6d5a17b85912018-10-11
71335-0622-4EA - Each71335-0622074b03d6-3c60-4583-9c95-e64b2e76c15012018-10-11
71335-0622-5EA - Each71335-0622c7de85f6-edcc-473d-8bb2-2dc00529ac1b12018-09-05
71335-0622-6EA - Each71335-062265b55ecc-f9d8-44af-b8d4-5564b95b082512018-10-11
71335-0622-7EA - Each71335-0622d39f72fe-e8a8-49f9-bc8b-7b94f883006a12018-10-11
57896-981-01EA - Each57896-981a27fc58c-b6ba-404b-8692-81e83053868712013-02-13
57896-981-10EA - Each57896-9812ba797b8-4f6d-47a9-a1e6-1cfc7031fa1c12017-05-04
57896-981-12EA - Each57896-981f0f0d829-ac3d-4cea-bf55-9166def6b6f012016-03-04
57896-981-20EA - Each57896-98181ff5719-941d-4fe2-9cd5-77089991cde912022-03-09
57896-981-30EA - Each57896-981641fb666-6519-46d4-ae60-d435b7c86c1e12018-11-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
ndc (product): 57896-981
Aspirin Low DoseASPIRINBryant Ranch Prepack61ecf3c9-42fa-4ae4-bd3b-694090477b9a2024-07-09WarningsExact identifier
ndc (package): 71335-0622-2
ndc (package): 71335-0622-8
ndc (package): 71335-0622-5
ndc (package): 71335-0622-7
ndc (package): 71335-0622-1
ndc (package): 71335-0622-3
ndc (package): 71335-0622-6
ndc (package): 71335-0622-4
ndc (package): 71335-0622-9
ndc (product): 71335-0622
ndc11 (package): 71335062208
ndc11 (package): 71335062209
ndc11 (package): 71335062203
ndc11 (package): 71335062206
ndc11 (package): 71335062201
ndc11 (package): 71335062202
ndc11 (package): 71335062205
ndc11 (package): 71335062204
ndc11 (package): 71335062207
spl id: 6be9330f-7f09-4cbb-8638-860acfed649b
spl set id: 61ecf3c9-42fa-4ae4-bd3b-694090477b9a

Reported adverse events (FAERS/openFDA)#

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