Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Excedrin Extra Strength Headache
- Manufacturer
- JC World Bell Wholesale Co., Inc | Haleon US Inc. | JC World Bell Wholesale Co., Inc.
- Effective date
- 2024-12-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:48:19
Label at a glance#
ProductExcedrin Extra Strength Headache
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 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 ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
Purposes
Pain reliever
Pain reliever
Pain reliever aid
*nonsteroidal anti-inflammatory drug
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 caffeinecontaining 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
Otherinformation
• 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
benzoic acid, carnauba wax, FD&C blue no. 1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide
Questionsorcomments?
1-800-468-7746
Package Labeling: 50269-158-01
Package Labeling: 50269-158-02
Package Labeling: 50269-158-03
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 2 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 2 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 2 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 2 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 2 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 2 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 2 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 2 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 2 |
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 |
|---|---|---|---|---|---|---|
| 50269-158-01 | Excedrin Extra Strength Headache | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 2 | |
| 50269-158-01 | Excedrin Extra Strength Headache | 25 in 1 BOX | TABLET, FILM COATED | 25 | 2 | |
| 50269-158-02 | Excedrin Extra Strength Headache | 6 in 1 BOX | TABLET, FILM COATED | 6 | 2 | |
| 50269-158-02 | Excedrin Extra Strength Headache | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 2 | |
| 50269-158-03 | Excedrin Extra Strength Headache | 6 in 1 BOX | TABLET, FILM COATED | 6 | 2 | |
| 50269-158-03 | Excedrin Extra Strength Headache | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Excedrin Extra Strength Headache
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- BENZOIC ACID
- CARNAUBA WAX
- FD&C BLUE NO. 1
- HYPROMELLOSE, UNSPECIFIED
- LIGHT MINERAL OIL
- LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 20
- POVIDONE
- PROPYLENE GLYCOL
- SORBITAN MONOLAURATE
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- ASPIRIN
- ACETYLSALICYLIC ACID
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50269-158 | 50269-158-01, 50269-158-02, 50269-158-03 |
| 0067-2002 |
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 |
|---|---|---|---|---|---|---|
| 29f4d22e-da00-b685-e063-6294a90a8a9c | 29b764c7-3d07-5191-e063-6294a90a9c30 | 2024-12-23 | Warnings | 29f4d22e-da00-b685-e063-6294a90a8a9c 29b764c7-3d07-5191-e063-6294a90a9c30 | ||
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Haleon US Holdings LLC | 61802b27-c9ec-4386-9d44-45e8b1e558b7 | 2024-01-28 | Warnings | 0067-2002 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.