Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches
Excedrin Extra Strength and Excedrin Tension Headache
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2026-02-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:46:54
Label at a glance#
ProductExcedrin Extra Strength and Excedrin Tension Headache
Active ingredientACETAMINOPHEN, CAFFEINE, ASPIRIN
Label structure18 sections
Dosage and administration
do not use more than directed adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years: ask a doctor
Contacts and useful links#
Websitewww.excedrin.com
www.excedrin.com
www.excedrin.comLabel contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 500 mg
Caffeine 65 mg
Purposes
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
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.
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 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
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 heartbeat.
Do not use
- if you are allergic to acetaminophen
- 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
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Stop use and ask a doctor if
- any new symptoms occur
- 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
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use.
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
- adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 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
benzoic acid, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions or comments?
1-800-468-7746
Active ingredients (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 & 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 a loss of hearing occurs
- painful area is red or swollen
- pain gets worse or last 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 during the last three 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.
Directions
- do not use more than directed
- 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
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
benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
Questions or comments?
1-800-468-7746
Principal Display Panel (Excedrin Tension Headache)
NDC 0067-8139-01
EXCEDRIN ®
TENSION HEADACHE
Acetaminophen and Caffeine
Pain Reliever / Pain Reliever Aid
Aspirin Free
24CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare,
Warren, NJ 07059
©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies
Visit us at www.excedrin.com
46177299
Principal Display Panel (Excedrin Extra Strength)
NDC 0067-2000-91
EXCEDRIN ®
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever / Pain Reliever Aid
100 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare,Warren, NJ 07059
©2015 GSK group of companies or its licensor. All rights reserved.
Visit us at www.excedrin.com
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.
46172044
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 5 |
| 307686 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet | PSN | 5 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 5 |
| 404172 | EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral Tablet | PSN | 5 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 5 |
| 404172 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache] | SBD | 5 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 5 |
| 307686 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet | SCD | 5 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 5 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 5 |
| 307686 | APAP 500 MG / Caffeine 65 MG Oral Tablet | SY | 5 |
| 404172 | APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache] | SY | 5 |
| 404172 | Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral Tablet | SY | 5 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 5 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 5 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 5 |
| 404172 | Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral Tablet | SY | 5 |
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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-8151-01 | 2023-03-28 | C162847 | 48780-1 | e4f33bdf-b2f2-d8a0-e053-dadaa90a6e4e | Drug Facts |
| 0067-8151-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b2f2-d8a0-e053-dadaa90a6e4e | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-2000-91 | Excedrin Extra Strength and Excedrin Tension Headache | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 65 mg | 5 |
| 0067-2000-91 | Excedrin Extra Strength and Excedrin Tension Headache | 1 in 1 CARTON | TABLET, FILM COATED | 65 mg | 5 | |
| 0067-8139-01 | Excedrin Extra Strength and Excedrin Tension Headache | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 500 mg | 5 |
| 0067-8139-01 | Excedrin Extra Strength and Excedrin Tension Headache | 1 in 1 CARTON | TABLET, FILM COATED | 65 mg | 5 | |
| 0067-8151-01 | Excedrin Extra Strength and Excedrin Tension Headache | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8139-01 | EA - Each | 0067-8139 | f7c98859-4508-488d-b72d-51329ba13e79 | 1 | 2017-07-07 |
| 0067-8139-02 | EA - Each | 0067-8139 | 09717a78-cbda-4ec5-b388-d04a131c9a60 | 1 | 2022-12-07 |
| 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 |
Products#
Every source-derived product name is available through these pages.
- Excedrin Extra Strength and Excedrin Tension Headache
- Acetaminophen, Aspirin (NSAID), and Caffeine
- Excedrin Tension Headache
- Acetaminophen, Caffeine
- BENZOIC ACID
- D&C RED NO. 27 ALUMINUM LAKE
- FD&C BLUE NO. 2
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- CAFFEINE
- Excedrin Extra Strength Pain Reliever
- CARNAUBA WAX
- FD&C BLUE NO. 1
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- LIGHT MINERAL OIL
- POLYSORBATE 20
- PROPYLENE GLYCOL
- DIMETHICONE, UNSPECIFIED
- SORBITAN MONOLAURATE
- ASPIRIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0067-8151 | 0067-8151-01 |
| 0067-8139 | 0067-8139-01 |
| 0067-2000 | 0067-2000-91 |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.