Aspirin
Aspirin 325mg (NSAID) *nonsterhoidal anti-inflammatory drug
372be427-acbd-c10c-e063-6294a90a572d
HUMAN OTC DRUG LABEL
Jun 9, 2025
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label
INDICATIONS & USAGE SECTION
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
Keep out of reach of children
In case of overdose, get medical help or contact a poison control center right away.
OTC - QUESTIONS SECTION
Questions or Comments?
Call 1-888-296-9067
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Aspirin 325mg (NSAID)
Nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain Reliever / Fever Reducer
OTC - DO NOT USE SECTION
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
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
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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for gout, diabetes, arthritis
DOSAGE & ADMINISTRATION SECTION
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
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
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
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
Inactive Ingredients
Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol