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Bayer

Bayer Corporation Consumer Care Division

BAYER ASPIRIN


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each powder pouch)

Aspirin 500 mg (NSAID)nonsterodial anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Bayer Uses

temporarily relieves

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

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
  • asthma (wheezing)
  • facial swelling
  • 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
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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

  • adults and children 12 years and over: take contents of 1 powder pouch every 4 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 8 powder pouches in 24 hours.
  • children under 12 years: consult a doctor

Bayer Other information

  • Phenylketonurics: Contains Phenylalanine 5.6 mg Per Powder Pouch
  • save carton for full directions and warnings
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, flavor, isomalt

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 500 mg Pouch Carton

See new warings information

NEW!

Aspirin (NSAID) Pain Reliever/Fever Reducer

BAYER ®

EXTRA STRENGTH

FAST RELEASE
POWDER

Dissolves Quickly
on your Tongue for
FAST PAIN RELIEF

citrus burst

10 SINGLE DOSE
POUCHES

Bayer

Bayer

Aspirin POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-2500
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 500 mg

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0280-2500-10 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-06-30


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Be sure to consult your doctor before taking any medication!
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