Indications and uses
• temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps
Excedrin
- Manufacturer
- Select Consumer Group
- Effective date
- 2025-12-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:28:53
Label at a glance#
ProductExcedrin Extra Strength Headache
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure11 sections
Dosage and administration
• 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 • children under 12 years: ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Uses
• temporarily relieves minor aches and pains due to:
- • headache
- • a cold
- • arthritis
- • muscular aches
- • toothache
- • premenstrual and menstrual cramps
Warnings
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:
• skin reddening
• blisters
• rash
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:
• hives
• facial swelling
• asthma (wheezing)
• shock
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
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.
Do not use
• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma
Ask a doctor or pharmacist before use if you are taking
• a prescription drug for diabetes, gout, or arthritis
• any other drug, or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
- • feel faint
- • vomit blood
- • have bloody or black stools
- • have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms occur
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 at 20 weeks or later in 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.
Directions
• 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
• children under 12 years: ask a doctor
Other information
• store at 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep this box for important information.
Inactive ingredients (100 ct)
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
1-800-468-7746
Package/Label Principal Display Panel (2ct)
EXCEDRIN
EXTRA STRENTH HEADACHE
Acetaminophen 250 mg,Aspirin 250 mg
(NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever Aid
ACTUAL SIZE
2 CAPLETS
Packaged and Distributed by: Select Corporation, Carrollton TX
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies.
Package Principal Package Label 25 ct
EXCEDRIN
EXTRA STRENTH HEADACHE
Acetaminophen 250 mg,Aspirin 250 mg (NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever Aid
ACTUAL SIZE
25 CAPLETS
Packaged and Distributed by: Select Corporation, Carrollton TX
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies.
Package / Label Principal Display Panel 50ct.
EXCEDRIN
EXTRA STRENTH HEADACHE
Acetaminophen 250 mg,Aspirin 250 mg (NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever Aid
ACTUAL SIZE
50
Packaged and Distributed by: Select Corporation, Carrollton TX
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 3 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 3 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 3 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 3 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 3 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 3 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 3 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 3 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85237-1868-1 | ExcedrinExtra Strength Headache | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 3 | |
| 85237-1868-1 | ExcedrinExtra Strength Headache | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 | |
| 85237-1868-2 | ExcedrinExtra Strength Headache | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 | |
| 85237-1868-2 | ExcedrinExtra Strength Headache | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 3 | |
| 85237-1868-3 | ExcedrinExtra Strength Headache | 25 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 25 | 3 | |
| 85237-1868-3 | ExcedrinExtra Strength Headache | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 | |
| 85237-1868-6 | ExcedrinExtra Strength Headache | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 | |
| 85237-1868-6 | ExcedrinExtra Strength Headache | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | 3 |
Products#
Every source-derived product name is available through these pages.
- Excedrin Extra Strength Headache
- Acetaminophen, Aspirin (NSAID), Caffeine
- SODIUM STARCH GLYCOLATE TYPE A
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- STARCH, CORN
- CROSPOVIDONE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85237-1868 | 85237-1868-1, 85237-1868-2, 85237-1868-3, 85237-1868-6 |
| 0067-2003 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
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 Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Select Consumer Group | 3caa0a47-de83-90d2-e063-6394a90a3436 | 2025-12-27 | Warnings | 85237-1868-3 85237-1868-6 85237-1868-1 85237-1868-2 85237-1868 85237186801 85237186806 85237186803 85237186802 46fa8b27-fe58-4382-e063-6394a90a8965 3caa0a47-de83-90d2-e063-6394a90a3436 |
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Haleon US Holdings LLC | 61802b27-c9ec-4386-9d44-45e8b1e558b7 | 2024-01-28 | Warnings | 0067-2003 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.