Bayer Headache

Drug Facts

Active ingredients (in each caplet) Purpose

Aspirin 500 mg (NSAID)*………………………...................Pain reliever/fever reducer

Caffeine 32.5 mg……………………………….....................Pain reliever aid

*nonsteroidal anti-inflammatory drug

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • colds
  • muscle pain
  • minor pain of arthritis
• temporarily reduces fever

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

Label information

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

Label information

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

Label information

Ask a doctor or pharmacist before use if you are taking a prescription drug for

● gout

● diabetes

● arthritis

Label information

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

Label information

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.

Label information

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

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 #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)

Bayer®

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

Headache

FAST RELIEF AT THE SITE OF PAIN

50 COATED CAPLETS

500 MG

[Image in the official label — see DailyMed source]