Bayer Headache Ui 1600654
c0a92873-0914-6a86-e053-2995a90ac41c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
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
Dosage and Administration
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
Description
Drug Facts
Uses
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- colds
- muscle pain
- minor pain of arthritis
- temporarily reduces fever
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking a prescription drug for
● gout
● diabetes
● arthritis
Section 50569-3
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
Section 50570-1
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
Section 51727-6
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
Section 53413-1
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Section 53414-9
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.
Section 55106-9
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
Section 60561-8
Other information
● save carton for full directions and warnings
● Store at room temperature. Avoid excessive heat above 40ºC (104ºF).
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
Structured Label Content
Uses
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- colds
- muscle pain
- minor pain of arthritis
- temporarily reduces fever
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking a prescription drug for
● gout
● diabetes
● arthritis
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
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
Section 53413-1 (53413-1)
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Section 53414-9 (53414-9)
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.
Section 55106-9 (55106-9)
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
Section 60561-8 (60561-8)
Other information
● save carton for full directions and warnings
● Store at room temperature. Avoid excessive heat above 40ºC (104ºF).
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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:28.996336 · Updated: 2026-03-14T23:11:00.469021