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Excedrin
Acetaminophen, Asprin, Caffeine · Tablet, Coated
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Central Nervous System Stimulant [EPC] | EPC | All 93 members |
| Central Nervous System Stimulation [PE] | PE | All 95 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Decreased Platelet Aggregation [PE] | PE | All 39 members |
| Decreased Prostaglandin Production [PE] | PE | All 54 members |
| Methylxanthine [EPC] | EPC | All 30 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
| Platelet Aggregation Inhibitor [EPC] | EPC | All 29 members |
| Xanthines [CS] | CS | All 30 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 020802-001 | EXCEDRIN (MIGRAINE RELIEF) | TABLET | ACETAMINOPHEN; ASPIRIN; CAFFEINE | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 42 | Manufacturing (CMC) | Approved | May 15, 2023 | N/A |
| Supplement | 43 | Labeling | Approved | April 17, 2023 | Standard |
| Supplement | 40 | Manufacturing (CMC) | Approved | December 7, 2021 | N/A |
| Supplement | 38 | Labeling | Approved | November 3, 2021 | Standard |
| Supplement | 34 | Labeling | Approved | February 27, 2020 | Standard |
| Supplement | 33 | Labeling | Approved | April 15, 2019 | Standard |
| Supplement | 32 | Labeling | Approved | January 2, 2018 | Standard |
| Supplement | 31 | Labeling | Approved | October 12, 2017 | Standard |
| Supplement | 30 | Manufacturing (CMC) | Approved | September 13, 2017 | Standard |
| Supplement | 28 | Manufacturing (CMC) | Approved | April 29, 2016 | Standard |
| Supplement | 27 | Manufacturing (CMC) | Approved | January 28, 2016 | Standard |
| Supplement | 26 | Manufacturing (CMC) | Approved | November 17, 2015 | Standard |
| Supplement | 25 | Manufacturing (CMC) | Approved | July 30, 2014 | Standard |
| Supplement | 24 | Labeling | Approved | July 15, 2014 | Standard |
| Supplement | 22 | Labeling | Approved | April 15, 2014 | Standard |
| Supplement | 19 | Labeling | Approved | February 4, 2010 | Standard |
| Supplement | 15 | Labeling | Approved | January 31, 2007 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | August 27, 2004 | Standard |
| Supplement | 9 | Labeling | Approved | May 21, 2003 | Standard |
| Supplement | 7 | Manufacturing (CMC) | Approved | April 19, 2002 | Standard |
| Supplement | 6 | Manufacturing (CMC) | Approved | October 10, 2000 | Standard |
| Supplement | 4 | Labeling | Approved | September 7, 2000 | Standard |
| Supplement | 5 | Manufacturing (CMC) | Approved | April 26, 2000 | Standard |
| Supplement | 2 | Efficacy | Approved | October 7, 1999 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | August 20, 1999 | Standard |
| Supplement | 1 | Manufacturing (CMC) | Approved | October 22, 1998 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | January 14, 1998 | Standard |
Review documents
- 0 · Supplement · May 16, 2023
- 0 · Supplement · May 16, 2023
- 0 · Supplement · April 19, 2023
- 0 · Supplement · April 19, 2023
- 0 · Supplement · December 13, 2021
- 0 · Supplement · December 9, 2021
- 0 · Supplement · November 9, 2021
- 0 · Supplement · November 4, 2021
- 0 · Supplement · February 28, 2020
- 0 · Supplement · February 28, 2020
- 0 · Supplement · April 19, 2019
- 0 · Supplement · April 16, 2019
- 0 · Supplement · April 16, 2019
- 0 · Supplement · January 9, 2018
- 0 · Supplement · October 27, 2017
- 0 · Supplement · October 18, 2017
- 0 · Supplement · July 30, 2014
- 0 · Supplement · July 17, 2014
- 0 · Supplement · April 22, 2014
- 0 · Supplement · April 17, 2014
- 0 · Supplement · February 17, 2010
- 0 · Supplement · February 12, 2007
- 0 · Original application · July 13, 2005
- 0 · Supplement · August 31, 2004
- 0 · Supplement · June 8, 2003
- 0 · Supplement · June 8, 2003
- 0 · Supplement · October 7, 1999
- 0 · Supplement · October 7, 1999
- 0 · Supplement · October 7, 1999
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240305). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps
Purpose
openFDA Drug LabelingPurposes Pain reliever Pain reliever Pain reliever aid
Dosage and Administration
openFDA Drug LabelingDirections do not use more than directed adults: take 2 geltabs with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 geltabs in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 2 geltabs 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 Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. 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 never had migraines diagnosed by a health professional you have a headache that is different from your usual migraines you have the worst headache of your life you have fever and stiff neck you have headaches beginning after or caused by head injury, exertion, coughing or bending you experienced your first headache after the age of 50 you have daily headaches you have a migraine so severe as to require bed rest 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 you have problems or serious side effects from taking pain relievers or fever reducers you have vomiting with your migraine headache Ask a doctor or pharmacist before use if you are taking a prescription drug for: diabetes gout arthritis under a doctor’s care for any serious condition taking any other drug taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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 your migraine is not relieved or worsens after first dose new or unexpected symptoms occur ringing in the ears or loss of hearing occurs 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.
Do Not Use
openFDA Drug LabelingDo 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.
Stop Use
openFDA Drug LabelingStop 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 appear These could be signs of a serious condition.
Active Ingredient
openFDA Drug LabelingActive ingredients (in each GelTab) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 0067-2021-20 | 0067-2021 | Haleon US Holdings LLC | 1 BOTTLE in 1 CARTON (0067-2021-20) / 20 TABLET, COATED in 1 BOTTLE | September 13, 2011 |
| 0067-2021-24 | 0067-2021 | Haleon US Holdings LLC | 1 BOTTLE in 1 CARTON (0067-2021-24) / 24 TABLET, COATED in 1 BOTTLE | September 13, 2011 |
| 0067-2021-80 | 0067-2021 | Haleon US Holdings LLC | 1 BOTTLE in 1 CARTON (0067-2021-80) / 80 TABLET, COATED in 1 BOTTLE | September 13, 2011 |
| 0067-2035-20 | 0067-2035 | Haleon US Holdings LLC | 1 BOTTLE in 1 CARTON (0067-2035-20) / 20 TABLET, COATED in 1 BOTTLE | September 13, 2011 |
| 0067-2035-80 | 0067-2035 | Haleon US Holdings LLC | 1 BOTTLE in 1 CARTON (0067-2035-80) / 80 TABLET, COATED in 1 BOTTLE | September 13, 2011 |
| 0067-2021 | 0067-2021 | Haleon US Holdings LLC | — | September 13, 2011 |
| 0067-2035 | 0067-2035 | Haleon US Holdings LLC | — | September 13, 2011 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.