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BAYER Aspirin Extra Strength Caplets


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Aspirin 500 mg (NSAID) nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

● feel faint ● vomit blood ● have bloody or black stools

● have stomach pain that does not get better

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


OTC - QUESTIONS SECTION

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


Carton 100 caplets