BAYER  ADVANCED ASPIRIN EXTRA STRENGTH- aspirin tablet 
Bayer HealthCare LLC, Consumer Care

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.

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Bayer® Advanced Aspirin
Extra Strength

Drug Facts

Active ingredient (in each tablet)

Aspirin 500 mg (NSAID)1


1
nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

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 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.

Directions

Other information

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 www.BayerAdvancedAspirin.com

PRINCIPAL DISPLAY PANEL - 20 Tablet Carton

ADVANCED TABLET PACKS

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
BAYER
®
ADVANCED
ASPIRIN

MICRO-PARTICLE
TECHNOLOGY

EXTRA
STRENGTH

FAST, SAFE PAIN RELIEF

500mg | 20 Coated Tablets

OFFICIAL SPONSOR

PRINCIPAL DISPLAY PANEL - 20 Tablet Carton
BAYER   ADVANCED ASPIRIN EXTRA STRENGTH
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 (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 500 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax (UNII: R12CBM0EIZ) 5.00 mg
Silicon Dioxide (UNII: ETJ7Z6XBU4) 8.50 mg
Hypromelloses (UNII: 3NXW29V3WO) 16.00 mg
Sodium carbonate (UNII: 45P3261C7T) 25.00 mg
Zinc stearate (UNII: H92E6QA4FV) 4.61 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code BA;500
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0280-2610-20 1 in 1 CARTON
1 20 in 1 BOTTLE, PLASTIC
2 NDC:0280-2610-40 1 in 1 CARTON
2 40 in 1 BOTTLE, PLASTIC
3 NDC:0280-2610-80 1 in 1 CARTON
3 80 in 1 BOTTLE, PLASTIC
4 NDC:0280-2610-01 507000 in 1 DRUM
5 NDC:0280-2610-21 5 in 1 CARTON
5 4 in 1 POUCH
6 NDC:0280-2610-41 10 in 1 CARTON
6 4 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 12/01/2012
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 1/2013
Document Id: 6de24195-6fa5-428d-8aa2-ad4be9689ab7
Set id: b5c627a8-a765-4883-908f-13a41869bd58
Version: 3
Effective Time: 20130109
 
Bayer HealthCare LLC, Consumer Care