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BAYER Aspirin Extra Strength Caplets

Medically reviewed on September 19, 2017

Dosage form: tablet
Ingredients: ASPIRIN 500mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-2020

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 Aspirin Extra Strength Caplets

Drug Facts

Active ingredient (in each caplet)

Aspirin 500 mg (NSAID)


nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

Uses

temporarily relieves

  • headache
  • pain and fever of colds
  • muscle pain
  • menstrual pain
  • toothache
  • 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
  • if you have ever had an allergic reaction to this product or any of its ingredients

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 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 caplets every 4 to 6 hours not to exceed 8 caplets in 24 hours
  • children under 12 years: consult a doctor

Other Information
  • save carton for full directions and warnings
  • store at room temperature. Avoid excessive heat above 40ºC (104ºF).

Inactive ingredients

carnauba wax, corn starch, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

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

Carton 100 caplets

BAYER ASPIRIN  EXTRA STRENGTH CAPLETS
bayer aspirin extra strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2020
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
D&C RED NO. 7 
ALUMINUM OXIDE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
HYPROMELLOSES 
POWDERED CELLULOSE 
PROPYLENE GLYCOL 
SHELLAC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint CodeExtra;Strength;BAYER
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-2020-101 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/23/2014
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIOperations
Bayer HealthCare LLC Consumer Care072827066manufacture(0280-2020), pack(0280-2020)

 
Bayer HealthCare LLC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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