Active Ingredient (In Each Tablet)
Aspirin 325 mg (NSAID)
1 nonsteroidal anti-inflammatory drug
Bayer Genuine Aspirin Tablet, Coated
FDA Label NDC 29485-7533
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Bayer Genuine Aspirin (NDC 29485-7533). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves
- headache
- muscle pain
- toothache
- menstrual pain
- pain and fever of colds
- minor pain of arthritis
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 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
Ask A Doctor Or Pharmacist Before Use If You Are
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
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 or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever lasts more than 3 days
- 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 Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
- children under 12 years: consult a doctor
Other Information
- save carton for full directions and warnings
- store at room temperature
Inactive Ingredients
carnauba wax
corn starch, hypromellose, powdered cellulose, triacetinQuestions Or Comments?
1-800-331-4536
(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com
Principal Display Panel
GENUINE ASPIRIN
BAYER®
ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
THE WONDER DRUG®
325mg
Safe Pain Relief Plus
Lifesaving Benefits
4 Coated Tablets
GENUINE ASPIRIN
BAYER®
ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
THE WONDER DRUG®
325mg
Safe Pain Relief Plus
Lifesaving Benefits
6 Coated Tablets
GENUINE ASPIRIN
BAYER®
ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
THE WONDER DRUG®
325mg
Safe Pain Relief Plus
Lifesaving Benefits
30 Pouches
2 COATED TABLETS EACH
GENUINE ASPIRIN
BAYER®
ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
THE WONDER DRUG®
325mg
Safe Pain Relief Plus
Lifesaving Benefits
25 POUCHES
2 COATED TABLETS EACH
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