ASPIRIN

Manufacturer
Safecor Health, LLC
Effective date
2014-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:57

Label at a glance#

ProductASPIRIN
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

For the temporary relief of aches and pains due to: headache, colds, menstrual pain, muscle pain, toothache, minor pain of arthritis or as directed by your doctor

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION


Each tablet contains Aspirin 325 mg (NSAID)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Corn Starch, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

PURPOSE

OTC - PURPOSE SECTION

Pain Reliever

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the temporary relief of aches and pains due to:

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

WARNINGS

WARNINGS SECTION

Reyes'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 non-prescription 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 you are allergic to aspirin or any other pain reliever/fever reducer

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

As a doctor or pharmacist if you are taking a prescription drug for diabetes, gout or arthritis; taking any other drug; under a doctor’s care for any serious condition

Stop use and ask a doctor if • 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 in the painful area • any new symptoms occur • ringing in the ears or a loss of hearing occurs.

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 THE 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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 325 mg Robot Unit Dose Box Label
Aspirin 325 mg Robot Unit Dose Box Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
48433-30548433-305-01, 48433-305-10
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
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 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
5b102236-e994-4286-ba38-deb16b3252285b102236-e994-4286-ba38-deb16b3252282014-04-02WarningsExact identifier
spl id: 5b102236-e994-4286-ba38-deb16b325228
spl set id: 5b102236-e994-4286-ba38-deb16b325228

Reported adverse events (FAERS/openFDA)#

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