Indications and uses
temporary relief of minor aches and pains associated with ■ headache ■ common cold ■ sinusitis ■ toothache ■ muscular aches ■ arthritis ■ premenstrual and menstrual cramps
temporary relief of minor aches and pains associated with ■ headache ■ common cold ■ sinusitis ■ toothache ■ muscular aches ■ arthritis ■ premenstrual and menstrual cramps
Do not exceed recommended dosage. Drink a full glass of water with each dose. Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. Children under 12 years: ask a doctor
store at 20º-25ºC (68º-77ºF) keep carton for full product information do not use if imprinted safety seal under cap is broken or missing you may report serious side effects to 1-888-952-0050
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
* nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
temporary relief of minor aches and pains associated with ■ headache ■ common cold ■ sinusitis ■ toothache ■ muscular aches ■ arthritis ■ premenstrual and menstrual cramps
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
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.
In case of overdose, get medical help or contact a Poison Control Center immeaditely. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Drink a full glass of water with each dose.
Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
Children under 12 years: ask a doctor
corn starch, cros- carmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0000000492812 | GTIN-13: 0000000492812 EAN-13: 0000000492812 GTIN-12: 000000492812 UPC-A: 000000492812 GTIN storage (14 digits): 00000000492812 | 285---health-a2z-es-headache-relief-1.jpg |
| Barcode | EAN-13 | 0369168285262 | GTIN-13: 0369168285262 EAN-13: 0369168285262 GTIN-12: 369168285262 UPC-A: 369168285262 GTIN storage (14 digits): 00369168285262 | 285---health-a2z-es-headache-relief-1.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69168-285-24 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-285-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1cb4-f424-e053-dadaa90a57ce | Drug Facts |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69168-285 | 69168-285-24, 69168-285-37, 69168-285-26 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2018-12-28 | daily-update | 2026-08-27 00:01:50 |
| 5 | 2018-12-28 | daily-update | 2026-08-20 01:00:59 |
| 4 | 2018-12-28 | full-release | 2026-05-31 23:50:37 |
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 |
|---|---|---|---|---|---|---|
| 67c605e6-e658-46a9-9670-32a07260fafa | 6197eff5-0351-42ef-bb3f-cbc26e6d0d14 | 2018-12-28 | Warnings | 6197eff5-0351-42ef-bb3f-cbc26e6d0d14 |
Adverse event summaries are temporarily unavailable. Other product information remains available.