Bayer Headache UI 1600654
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
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
Uses
- temporarily relieves minor aches and pains due to: headachetoothachecoldsmuscle painminor pain of arthritis
- temporarily reduces fever
WARNINGS SECTION
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
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
OTC - ASK DOCTOR SECTION
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 faintvomit bloodhave bloody or black stoolshave 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
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.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
● save carton for full directions and warnings
● Store at room temperature. Avoid excessive heat above 40ºC (104ºF).
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Package Display 50 Count Carton
Bayer®
ASPIRIN (NSAID)/PAIN RELIEVER/FEVER REDUCER CAFFEINE/PAIN RELIEVER AID
Headache
FAST RELIEF AT THE SITE OF PAIN
50 COATED CAPLETS
500 MG