Your browser does not support JavaScript! BAYER ADVANCED ASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]
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BAYER ADVANCED ASPIRIN EXTRA STRENGTH (aspirin) tablet
[Bayer HealthCare LLC, Consumer Care]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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

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

  • 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.
  • 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 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0280-2610
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin500 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax5.00 mg
Silicon Dioxide8.50 mg
Hypromelloses16.00 mg
Sodium carbonate25.00 mg
Zinc stearate4.61 mg
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code BA;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-2610-201 in 1 CARTON
120 in 1 BOTTLE, PLASTIC
2NDC:0280-2610-401 in 1 CARTON
240 in 1 BOTTLE, PLASTIC
3NDC:0280-2610-801 in 1 CARTON
380 in 1 BOTTLE, PLASTIC
4NDC:0280-2610-01507000 in 1 DRUM
5NDC:0280-2610-215 in 1 CARTON
54 in 1 POUCH
6NDC:0280-2610-4110 in 1 CARTON
64 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34312/01/2012
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 1/2013
 
Bayer HealthCare LLC, Consumer Care

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