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 of age and over take 2 caplets every 6 hours; not more than 8 caplets in 24 hours under 12 years ask a doctor
store at 20°-25°C (68°-77°F) read all product information before using. Keep this card for important information.
Drug Facts
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 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 care 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.
| adults and children 12 years of age and over | take 2 caplets every 6 hours; not more than 8 caplets in 24 hours |
| under 12 years | ask a doctor |
benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcelluose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
1-800-452-0051
Repackaged and Distributed by:
Select Corporation
Carrollton, TX 75007
Packaged and distributed by Select Corporation with the permission of
GSK Consumer Healthcare, Warren, NJ 07059
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 1 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 1 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 1 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 1 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 1 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 1 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 1 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 1 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 1 |
| 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 |
|---|---|---|---|---|---|
| 52904-868-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-68c1-111a-e063-dadaa90a10e2 | Excedrin® Extra Strength |
| 52904-868-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-68c1-111a-e063-dadaa90a10e2 | Excedrin® Extra Strength |
| 52904-868-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-68c1-111a-e063-dadaa90a10e2 | Excedrin® Extra Strength |
| 52904-868-50 | 2024-01-30 | C162847 | 48780-1 | 1030e365-68c1-111a-e063-dadaa90a10e2 | Excedrin® Extra Strength |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52904-868-04 | Excedrin Extra Strength | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 | |
| 52904-868-04 | Excedrin Extra Strength | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 1 | |
| 52904-868-05 | Excedrin Extra Strength | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 1 | |
| 52904-868-05 | Excedrin Extra Strength | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 | |
| 52904-868-25 | Excedrin Extra Strength | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 | |
| 52904-868-25 | Excedrin Extra Strength | 25 in 1 CARTON | TABLET, FILM COATED | 25 | 1 | |
| 52904-868-50 | Excedrin Extra Strength | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 | |
| 52904-868-50 | Excedrin Extra Strength | 50 in 1 CARTON | TABLET, FILM COATED | 50 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-2000-10 | EA - Each | 0067-2000 | adfcd816-2ed6-4c72-8c5d-908c9756ab3f | 1 | 2015-11-12 |
| 0067-2000-20 | EA - Each | 0067-2000 | cbff9d6a-ce12-4fbb-ac40-512a94ce514a | 1 | 2014-11-05 |
| 0067-2000-24 | EA - Each | 0067-2000 | 3de1f192-e5db-479d-84d8-19456b946402 | 1 | 2012-07-24 |
| 0067-2000-30 | EA - Each | 0067-2000 | 1f7e4f47-6c08-41f8-861c-981a7184f7a4 | 1 | 2025-05-14 |
| 0067-2000-33 | EA - Each | 0067-2000 | dcae665d-7d8d-4cfb-a2f9-93b577535a3e | 1 | 2015-10-02 |
| 0067-2000-50 | EA - Each | 0067-2000 | 9b6938a9-715c-431b-bada-71e78baeda03 | 1 | 2012-07-24 |
| 0067-2000-77 | EA - Each | 0067-2000 | 7d621095-87ef-450a-891e-067811771251 | 1 | 2012-07-24 |
| 0067-2000-91 | EA - Each | 0067-2000 | 51e263ed-40ca-4508-82dd-ccf0854b9b21 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52904-868 | 52904-868-04, 52904-868-05, 52904-868-25, 52904-868-50 |
| 0067-2000 |
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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | a71074a6-cc19-4bb3-8c84-4e82a8906801 | 2024-04-22 | Warnings | 0067-2000 |
| 055e2c6d-5d40-4f69-a5f7-9f96df4894d2 | 60af6b21-9dc2-461e-a9bd-28d8e75cecb5 | 2022-03-24 | Warnings | 055e2c6d-5d40-4f69-a5f7-9f96df4894d2 60af6b21-9dc2-461e-a9bd-28d8e75cecb5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.