Aspirin 325mg (NSAID)

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2026-07-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
weekly-update
Hydrated at
2026-07-17 21:43:38

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure16 sections

Indications and uses

Temporarily relieves: Headache Pain and fever of colds toothache menstrual pain muscle pain minor pain of arthritis

Dosage and administration

Do not take more than directed. See overdose warning Drink a full glass of water with each dose Adults and children 12 years and older Take 1 or 2 tablets every 4 hours or 3 tablets every 6 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 325mg (NSAID)

Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever / Fever Reducer

Do Not Use

OTC - DO NOT USE SECTION

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

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:

Headache

Pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

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 behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a reare but serious illness.

Allergy Alert

Aspirin may cause severe allergic reaction, which may include, facial swelling, hives, shock, asthma (wheezing).

Stomach bleeding warning

This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you

  • Have had stomach ulcers or bleeding problems
  • Take blood thinning (anticogulant) or steroid drug
  • Are age 60 or older
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • Take more or for a longer time than directed
  • Have 3 or more alcoholic drinks every day while using this product

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • Stomach bleeding warning applies to you.
  • You have a history of stomach problems, such as heartburn
  • You have asthma
  • You have high blood pressure, heart disease, liver cirrhosis or kidney disease.
  • You are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for gout, diabetes, arthritis

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed. See overdose warning

Drink a full glass of water with each dose

Adults and children 12 years and older

  • Take 1 or 2 tablets every 4 hours or 3 tablets every 6 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

Stop Use and ask a doctor if

OTC - STOP USE SECTION

  • 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 stools, have stomach pain that does not get better
  • Ringing in the ears or loss of hearing occurs, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days.
  • New symptoms occur,
  • Redness or swelling is present
  • Thse could be signs of a serious condition

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 25ºC (77ºF)
  • Excursions permitted between 15ºC-30ºC (59ºF-86ºF)
  • See end flap for expiration date and lot number
  • Use by expiration date on package

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center right away.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by the Bayer Healthcare LLC. owner of the registered trademark Bayer®

Reorder No. 2023

Made in the USA

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cs-globe-aspirin-325mg-50pk-26.2cs-globe-aspirin-325mg-50pk-26.2

DailyMed Product Concepts#

Product concept, Relation, Version table
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bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-15869396-158-01, 69396-158-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-04-24full-release2026-06-01 01:55:00

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
ndc (package): 69396-158-01
ndc (package): 69396-158-05
ndc (product): 69396-158
ndc11 (package): 69396015805
ndc11 (package): 69396015801
spl id: 55f653d0-d7f6-cae2-e063-6294a90acfa9
spl set id: 227cefca-acc4-41d0-e063-6394a90a35b9

Reported adverse events (FAERS/openFDA)#

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