Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 softgels every 6 hours; not more than 8 softgels in 24 hours children under 12 years: ask a doctor
store at 20° - 25° C (68° - 77° F) close cap tightly after use read all product information before using.
Drug Facts
temporarily relieves minor aches and pains due to:
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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.
These could be signs of a serious condition.
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.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Beeswax, carboxymethyl cellulose, D&C Yellow No.10, ethanol, FD&C Blue No.1, gelatin, glycerin, HPMC, light liquid paraffin, PEG 400, purified water, shellac, sorbitol sorbitan solution, soya bean oil, soya lecithin, stearic acid, titanium dioxide
1-888-333-9792
DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0021-80 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7f75-d83d-e063-dadaa90ab31f | Extra Strength Headache Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0021-80 | Extra Strength Headache Relief | 80 in 1 BOTTLE | CAPSULE | 80 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-0021 | 0363-0021-80 |
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 |
|---|---|---|---|---|---|---|
| 9af00e2c-7599-4bcf-e053-2995a90a96f9 | a4463c1c-493c-4a86-ac4e-77671b7668ac | 2019-12-30 | Warnings | 9af00e2c-7599-4bcf-e053-2995a90a96f9 a4463c1c-493c-4a86-ac4e-77671b7668ac |
Adverse event summaries are temporarily unavailable. Other product information remains available.