Indications and uses
Uses temporarily relieves minor aches and pains due to: headache toothache colds muscle pain minor pain of arthritis temporarily reduces fever
Bayer Headache
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:04
Label at a glance#
ProductBayer Headache
Active ingredientASPIRIN, CAFFEINE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
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:
- headache
- toothache
- colds
- muscle pain
- minor 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 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
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0312843592186 | GTIN-13: 0312843592186 EAN-13: 0312843592186 GTIN-12: 312843592186 UPC-A: 312843592186 GTIN storage (14 digits): 00312843592186 | Bayer Aspirin Headache 50ct Final Artwork.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0064-01 | Bayer Headache | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 0280-0064-01 | Bayer Headache | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 0280-0064-02 | Bayer Headache | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 0280-0064-02 | Bayer Headache | 50 in 1 BOTTLE | TABLET | 50 | 4 |
Products#
Every source-derived product name is available through these pages.
- Bayer Headache
- Aspirin and caffeine
- CARNAUBA WAX
- HYPROMELLOSES
- PROPYLENE GLYCOL
- ASPIRIN
- D&C YELLOW NO. 10 ALUMINUM LAKE
- POWDERED CELLULOSE
- TITANIUM DIOXIDE
- CAFFEINE
- STARCH, CORN
- D&C RED NO. 30
- TRIACETIN
- SHELLAC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0064 | 0280-0064-01, 0280-0064-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| D&C YELLOW NO. 10 ALUMINUM LAKE | CQ3XH3DET6 | IACT |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| SHELLAC | 46N107B71O | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bayer Headache | ASPIRIN AND CAFFEINE | Bayer HealthCare LLC. | c0a92873-0914-6a86-e053-2995a90ac41c | 2025-12-04 | Warnings | 0280-0064-01 0280-0064-02 0280-0064 00280006402 00280006401 45263661-3ac2-6283-e063-6394a90ac1ec c0a92873-0914-6a86-e053-2995a90ac41c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.