Excedrin

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:10:44

Label at a glance#

ProductExcedrin Extra Strength Pain Reliever
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-452-0051

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-2001-05

EXCEDRIN

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

100CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL INPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2018 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

62000000032208

62000000032208_Excedrin ES Caplet_100 CT.JPG
62000000032208_Excedrin ES Caplet_100 CT.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN10
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN10
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD10
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD10
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY10
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY10
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY10
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY10
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-2001-012024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-022024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-032024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-042024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-052024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-062024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-072024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-082024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-092024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-142024-02-05C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-012024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-022024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-032024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-042024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-052024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-062024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-072024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-082024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-092024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-142024-01-30C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-012023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-022023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-032023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-042023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-052023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-062023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-072023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-082023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-092023-02-13C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-012022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-022022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-032022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-042022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-052022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-062022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-072022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-082022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2001-092022-07-29C16284748780-1e4f33bdf-ae22-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2001-01ExcedrinExtra Strength Pain Reliever2 in 1 POUCHTABLET, FILM COATED210
0067-2001-02ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-02ExcedrinExtra Strength Pain Reliever24 in 1 BOTTLETABLET, FILM COATED2410
0067-2001-03ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-03ExcedrinExtra Strength Pain Reliever30 in 1 BOTTLETABLET, FILM COATED3010
0067-2001-04ExcedrinExtra Strength Pain Reliever50 in 1 BOTTLETABLET, FILM COATED5010
0067-2001-04ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-05ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-05ExcedrinExtra Strength Pain Reliever100 in 1 BOTTLETABLET, FILM COATED10010
0067-2001-06ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-06ExcedrinExtra Strength Pain Reliever125 in 1 BOTTLETABLET, FILM COATED12510
0067-2001-07ExcedrinExtra Strength Pain Reliever200 in 1 BOTTLETABLET, FILM COATED20010
0067-2001-07ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-08ExcedrinExtra Strength Pain Reliever300 in 1 BOTTLETABLET, FILM COATED30010
0067-2001-08ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-09ExcedrinExtra Strength Pain Reliever250 in 1 BOTTLETABLET, FILM COATED25010
0067-2001-09ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-14ExcedrinExtra Strength Pain Reliever8 in 1 VIALTABLET, FILM COATED810
0067-2001-14ExcedrinExtra Strength Pain Reliever1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2001EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 19 package rows20240407_1b5ff867-5442-4cf8-bd1e-530093cc88f8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC1b5ff867-5442-4cf8-bd1e-530093cc88f82024-04-05WarningsExact identifier
ndc (package): 0067-2001-14
ndc (package): 0067-2001-07
ndc (package): 0067-2001-01
ndc (package): 0067-2001-06
ndc (package): 0067-2001-04
ndc (package): 0067-2001-08
ndc (package): 0067-2001-02
ndc (package): 0067-2001-09
ndc (package): 0067-2001-05
ndc (package): 0067-2001-03
ndc (product): 0067-2001
ndc11 (package): 00067200101
ndc11 (package): 00067200106
ndc11 (package): 00067200108
ndc11 (package): 00067200103
ndc11 (package): 00067200104
ndc11 (package): 00067200109
ndc11 (package): 00067200102
ndc11 (package): 00067200114
ndc11 (package): 00067200105
ndc11 (package): 00067200107
spl id: 155eb367-99df-1f50-e063-6294a90a21d6
spl set id: 1b5ff867-5442-4cf8-bd1e-530093cc88f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.