Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
do not use more than directed (see Overdose Warning ) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor
Each caplet contains: Magnesium 0.58 mg store at controlled room temperature 20º - 25º C (68º - 77º F) read all product information before using. Keep this box for important information
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.
Aspirin may cause a severe allergic reaction which may include:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor or pharmacist before use if you are taking
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.
Keep out of reach of children
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. 1(800) 222-1222
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc
1-888-333-9792
COMPARE TO THE ACTIVE
INGREDIENTS OF EXCEDRIN®
EXTRA STRENGTH*
EXTRA STRENGHT
HEADACHE RELIEF
ACETAMINOPHE, ASPIRIN (NSAID) AND CAFFEINE
PAIN RELEIVER / PAIN RELEIVER AID
| 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 |
|---|---|---|---|---|---|
| 68210-0107-1 | 2026-01-29 | C162847 | 48780-1 | 49896155-b645-586f-e063-e6dba90add90 | EXTRA STRENGTH HEADACHE RELIEF |
| 68210-0107-3 | 2026-01-29 | C162847 | 48780-1 | 49896155-b645-586f-e063-e6dba90add90 | EXTRA STRENGTH HEADACHE RELIEF |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-0107-1 | EXTRA STRENGHT HEADACHE RELIEF | 100 in 1 BOTTLE | TABLET | 100 | 8 | |
| 68210-0107-1 | EXTRA STRENGHT HEADACHE RELIEF | 1 in 1 CARTON | TABLET | 1 | 8 | |
| 68210-0107-3 | EXTRA STRENGHT HEADACHE RELIEF | 300 in 1 PACKAGE | TABLET | 300 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-0107 | EXTRA STRENGHT HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [SPIRIT PHARMACEUTICAL LLC] | 8 | Legacy NDC, 3 package rows | 20250101_0ef44587-c160-403f-b8a6-8bedf8e2eb8e.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-0107 | 68210-0107-1, 68210-0107-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 2a806785-9ca8-322e-e063-6294a90a35f2 | 0ef44587-c160-403f-b8a6-8bedf8e2eb8e | 2024-12-30 | Warnings | 2a806785-9ca8-322e-e063-6294a90a35f2 0ef44587-c160-403f-b8a6-8bedf8e2eb8e |
Adverse event summaries are temporarily unavailable. Other product information remains available.