MedPath

Aspirin

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

Approved
Approval ID

372be427-acbd-c10c-e063-6294a90a572d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

Trifecta Pharmaceuticals USA LLC

DUNS: 079424163

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aspirin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69396-173
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (5)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

Label

2027 GLOBE ASPIRIN TABLETS 325MG BOTTLE REV04 060525 CDER

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/24/2024

Uses

Temporarily relieves:

Headache

Pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/19/2024

Keep out of reach of children

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2023

Questions or Comments?

Call 1-888-296-9067

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/24/2024

Active Ingredient

Aspirin 325mg (NSAID)

Nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/21/2023

Purpose

Pain Reliever / Fever Reducer

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/24/2024

Do Not Use

  • 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

WARNINGS SECTION

LOINC: 34071-1Updated: 8/24/2024

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 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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/23/2024

Ask a doctor before use if

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 8/23/2024

Ask a doctor or pharmacist before use if you are

taking a prescription drug for gout, diabetes, arthritis

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/23/2024

Directions

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/23/2024

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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/23/2024

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/23/2023

Distributed By:

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/23/2024

Inactive Ingredients

Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol

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Aspirin - FDA Drug Approval Details