FDA.reportPublic FDA data

Excedrin

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:09:42

Label at a glance#

ProductExcedrin Tension Headache
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure9 sections

Indications and uses

• temporarily relieves minor aches and pain due to: • headache • muscular aches

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

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches

Warnings

WARNINGS SECTION

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

WARNINGS SECTION

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning:

WARNINGS SECTION

  • 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:

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • you have liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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
  • 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

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, 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?

OTC - QUESTIONS SECTION

1-800-468-7746

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXCEDRIN

TENSION HEADACHE

ASPIRIN-FREE

Acetaminophen 500 mg, Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER SAFETY SEAL UNDER CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201976

Excedrin Tension Headache 24 ct
Excedrin Tension Headache 24 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN7
404172EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral TabletPSN7
404172acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SBD7
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD7
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY7
404172APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SY7
404172Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral TabletSY7
404172Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8139-01ExcedrinTension Headache24 in 1 BOTTLETABLET, FILM COATED247
0067-8139-01ExcedrinTension Headache1 in 1 CARTONTABLET, FILM COATED17
0067-8139-02ExcedrinTension Headache100 in 1 BOTTLETABLET, FILM COATED1007
0067-8139-02ExcedrinTension Headache1 in 1 CARTONTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8139EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240315_12c074d1-81ac-47d2-8747-b018cda0058a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8139-01EA - Each0067-8139f7c98859-4508-488d-b72d-51329ba13e7912017-07-07
0067-8139-02EA - Each0067-813909717a78-cbda-4ec5-b388-d04a131c9a6012022-12-07

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-81390067-8139-01, 0067-8139-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML · Source PDF

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC2c8df1c7-7864-48df-939c-d9ae22e0f52c2026-02-23WarningsExact identifier
ndc (package): 0067-8139-01
ndc11 (package): 00067813901
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
ndc (package): 0067-8139-02
ndc11 (package): 00067813902
Excedrin Tension HeadacheACETAMINOPHEN, CAFFEINEHaleon US Holdings LLC12c074d1-81ac-47d2-8747-b018cda0058a2024-03-13WarningsExact identifier
ndc (package): 0067-8139-02
ndc (package): 0067-8139-01
ndc (product): 0067-8139
ndc11 (package): 00067813901
ndc11 (package): 00067813902
spl id: dd87f543-c93b-4204-a601-368db2fec725
spl set id: 12c074d1-81ac-47d2-8747-b018cda0058a

Reported adverse events (FAERS/openFDA)#

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