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Name:Bayer Advanced Aspirin Extra Strength
Manufacturer:Bayer Corporation Consumer Care Division
Category:Over-the-counter (OTC) Marketed Drugs

Bayer® Advanced Aspirin Extra Strength 500 mg Coated Tablet

Bayer Corporation Consumer Care Division

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Bayer® Advanced Aspirin Extra Strength
500 mg Coated Tablet

Drug Facts

Active ingredient (in each tablet)

Aspirin 500 mg (NSAID)1

nonsteroidal anti-inflammatory drug


Pain reliever/fever reducer


temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • pain and fever of colds
  • toothache


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
  • you have a sodium-restricted diet

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 right away.


  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information

  • each tablet contains: sodium 72 mg
  • store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use.
  • save carton for full directions and warnings

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate

Questions or comments?

1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Carton






500mg | 20 Coated Tablets



PRINCIPAL DISPLAY PANEL - 500 mg Tablet Carton

aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2610
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 500 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax 5.00 mg
Silicon Dioxide 8.50 mg
Hypromelloses 16.00 mg
Sodium carbonate 25.00 mg
Zinc stearate 4.61 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code BA;500
# Item Code Package Description Multilevel Packaging
1 NDC:0280-2610-20 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 20 TABLET ( TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0280-2610-20)
2 NDC:0280-2610-40 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 40 TABLET ( TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0280-2610-40)
3 NDC:0280-2610-80 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 80 TABLET ( TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0280-2610-80)
4 NDC:0280-2610-01 507000 TABLET ( TABLET) in 1 DRUM None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 12/01/2010

Labeler - Bayer Corporation Consumer Care Division (785159372)

Revised: 03/2011 Bayer Corporation Consumer Care Division

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2019 by Dionisios Fentas || Terms of Use


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