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Excedrin

Acetaminophen, Asprin, Caffeine · Tablet, Coated

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Excedrin Migraine Geltabs
Generic name
Acetaminophen, Asprin, Caffeine
Dosage form
Tablet, Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
2
Packages
5
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Acetaminophen 250 mg/1 313782 View
Aspirin 250 mg/1 994535 View
Caffeine 65 mg/1 994535 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
020802
Application type
NDA · New Drug Application
Approval date
January 14, 1998
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
27
Products approved under application 020802.
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 Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes 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
Most recent submissions on application 020802.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20240305 HUMAN OTC DRUG · 20240128

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Purposes Pain reliever Pain reliever Pain reliever aid

Dosage and Administration

openFDA Drug Labeling

Directions 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 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 • 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 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 Labeling

Active ingredients (in each GelTab) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
679,519
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.