Dosage and administration
do not use more than directed drink a full glass of water with each dose. adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor
do not use more than directed drink a full glass of water with each dose. adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
* nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
temporarily relieves minor aches and pains due to
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 specifically
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
(1-800-222-1222) right away. Quick medical attention is
critical for adults as well as for children even if you do not
notice the signs or symptoms.
adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
children under 12 years: ask a doctor
store at 20°-25°C (68°-77°F)
corn starch, croscarmellose sodium, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized
starch, silicon dioxide, stearic acid, titanium dioxide
Call 1-877-290-4008
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0810159835541 | GTIN-13: 0810159835541 EAN-13: 0810159835541 GTIN-12: 810159835541 UPC-A: 810159835541 GTIN storage (14 digits): 00810159835541 | headache-relief-1.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85828-285-93 | Headache ReliefExtra Strength | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 2 | |
| 85828-285-93 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 85828-285 | 85828-285-93 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Grocery Outlet | 7398a372-7679-423b-a3ca-8da905a979dd | 2026-03-17 | Warnings | 85828-285-93 85828-285 85828028593 4c1e439b-8e75-4950-8e73-8fe0e51a50ff 7398a372-7679-423b-a3ca-8da905a979dd |
Adverse event summaries are temporarily unavailable. Other product information remains available.