ASPIRIN

Manufacturer
Liberty Pharmaceuticals, Inc.
Effective date
2013-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:51

Label at a glance#

ProductASPIRIN
Active ingredientASPIRIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains Aspirin 325 mg

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, Hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

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


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

DOSAGE & ADMINISTRATION SECTION

Directions: 

Drink a full glass of water with each dose

Adults and children 12 years and over:  take 1 to 2 tablets every 4 hours while symptoms last

Do not take more than 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years: consult a doctor

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.

OTC - PURPOSE SECTION

Pain Reliever

INDICATIONS & USAGE SECTION

Uses:

For the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor.

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE LABELIMAGE LABEL 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN1
198467aspirin 325 MG Delayed Release Oral TabletSCD1
198467ASA 325 MG Delayed Release Oral TabletSY1
198467aspirin 325 MG Enteric Coated Oral TabletSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-1130-902020-01-31C16284748780-19d75b9d0-b074-f424-e053-dadaa90a57ceASPIRIN FOR TIME CAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1130-90ASPIRIN90 in 1 BOTTLE, PLASTICTABLET, COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1130ASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20130909_2d368df5-c176-435d-b8b9-a171f972fd14.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-1130-90EA - Each0440-1130c5610990-9ce7-493d-a9ba-b11fc6cfa7bd12013-10-17
49483-011-01EA - Each49483-0111a8b4a59-e054-44a3-8315-d49574cf89e312012-07-24
49483-011-10EA - Each49483-011d996d20c-42cd-41a2-a29a-679d7f395c7612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0440-11300440-1130-90
49483-011

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form

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
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
ndc (product): 49483-011
c2183561-837b-447a-8f41-8d9ac34571882d368df5-c176-435d-b8b9-a171f972fd142013-09-05WarningsExact identifier
spl id: c2183561-837b-447a-8f41-8d9ac3457188
spl set id: 2d368df5-c176-435d-b8b9-a171f972fd14

Reported adverse events (FAERS/openFDA)#

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