Aspirin 325mg

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:47:01

Label at a glance#

ProductAspirin 325mg
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache  menstrual pain  a cold  toothache  muscle pain minor pain of arthritis  or as recommended by your doctor

Dosage and administration

do not take more than directed  drink a full glass of water with each dose  adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ·  children under 12 years: do not use unless directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • headache 
  • menstrual pain 
  • a cold 
  • toothache 
  • muscle pain
  • minor pain of arthritis 
  • or as recommended by your doctor

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

  • 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

Ask a doctor before use if

  • stomach bleeding warning applies to you 
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic 
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 
  • you have asthma you
  • are taking a prescription drug for diabetes, arthritis, or gout

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: 
  • vomit blood 
  • feel faint
  • have bloody or black stools 
  • have stomach pain that does not get better 
  • ringing in the ears or a loss of hearing occurs 
  • new symptoms occur · pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days 
  • redness or swelling is present. These could 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.

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 take more than directed 
  • drink a full glass of water with each dose 
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor · 
  • children under 12 years: do not use unless directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
  • see end flap for expiration date and lot number

Inactive Ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate,
stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

SPL UNCLASSIFIED SECTION

Questions or Comments? 1-888-462-4166

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-041-01EA - Each71800-041f2a8c0ff-804c-4844-a097-cf4d49f88b5012025-05-14

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-04171800-041-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46e0f0e2-a5a8-a6dc-e063-6394a90a3dfd1a754ef1-b25d-4df0-9635-8ffe6dd7078a2025-12-26WarningsExact identifier
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spl set id: 1a754ef1-b25d-4df0-9635-8ffe6dd7078a

Reported adverse events (FAERS/openFDA)#

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