Bayer

Bayer HealthCare LLC

BAYER HEADACHE RELIEF

FULL PRESCRIBING INFORMATION: CONTENTS*

• Bayer Uses
• Warnings
  • Reye's syndrome
  • Allergy alert
  • Stomach bleeding warning
  • Ask a doctor before use if
  • Stop use and ask a doctor if
• Directions
• Bayer Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 50 Caplet Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Bayer Uses

for the temporary relief of

• headache
• muscle aches and pains

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

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
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• 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 2 caplets every 6 hours not to exceed 8 caplets in 24 hours
• children under 12 years: consult a doctor

Bayer Other information

• save carton for full directions and warnings
• store at room temperature

Inactive ingredients

carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 Caplet Carton

ASPIRIN (NSAID) / PAIN RELIEVER CAFFEINE / PAIN RELIEVER AID

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HEADACHE
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50 Coated Caplets

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