Bayer Headache
Aspirin and caffeine · Tablet · Oral
Active ingredient
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 Uses temporarily relieves minor aches and pains due to: headache toothache colds muscle pain minor pain of arthritis temporarily reduces fever
Warnings
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 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 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.
Do not use
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
Ask a doctor before use
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 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
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for ● gout ● diabetes ● arthritis
Pregnancy or breast-feeding
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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
Inactive ingredients
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?
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Label text from the FDA structured product label by Bayer HealthCare LLC. (revised Dec 4, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
Bayer Headache NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0280-0064 | Aspirin 500 mg/1; Caffeine 32.5 mg/1 Tablet | Bayer HealthCare LLC. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Bayer Headache used for?
Uses Uses temporarily relieves minor aches and pains due to: headache toothache colds muscle pain minor pain of arthritis temporarily reduces fever
Who makes Bayer Headache?
Bayer Headache is listed by 1 labeler in the FDA NDC directory, including Bayer HealthCare LLC..