Excedrin Extra Strength

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2022-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:55:56

Label at a glance#

ProductExcedrin Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 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 of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever aid
*nonsteroidal anti-inflammatory drug

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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 care 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 of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• store at 20°-25°C (68°-77°F)
• read all product information before using. Keep this carton for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, carnauba wax, FD&C blue #1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-468-7746

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaged and Distributed by
Navajo Mfg. Co. Inc. with permission
of GSK Consumer Healthcare
GSK Consumer Healthcare
, Warren, NJ 07059
©2021 GSK group of companies or its licensor.
All rights reserved.
(800) 468-7746 Visit us at www.excedrin.com

The Excedrin trademark is owned by or licensed to the group of GSK companies
The Handy Solutions trademark is owned by Navajo Manufacturing Company Inc.

Extra Strength ExcedrinExtra Strength Excedrin

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2000-10EA - Each0067-2000adfcd816-2ed6-4c72-8c5d-908c9756ab3f12015-11-12
0067-2000-20EA - Each0067-2000cbff9d6a-ce12-4fbb-ac40-512a94ce514a12014-11-05
0067-2000-24EA - Each0067-20003de1f192-e5db-479d-84d8-19456b94640212012-07-24
0067-2000-30EA - Each0067-20001f7e4f47-6c08-41f8-861c-981a7184f7a412025-05-14
0067-2000-33EA - Each0067-2000dcae665d-7d8d-4cfb-a2f9-93b577535a3e12015-10-02
0067-2000-50EA - Each0067-20009b6938a9-715c-431b-bada-71e78baeda0312012-07-24
0067-2000-77EA - Each0067-20007d621095-87ef-450a-891e-06781177125112012-07-24
0067-2000-91EA - Each0067-200051e263ed-40ca-4508-82dd-ccf0854b9b2112012-07-24

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-14167751-141-01, 67751-141-02, 67751-141-03
0067-2000

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLCa71074a6-cc19-4bb3-8c84-4e82a89068012024-04-22WarningsExact identifier
ndc (product): 0067-2000
f7e52f48-0360-a10c-e053-6294a90aff7e14bec07c-438e-4fdd-8131-8ecd484e81c62023-03-27WarningsExact identifier
spl set id: 14bec07c-438e-4fdd-8131-8ecd484e81c6

Reported adverse events (FAERS/openFDA)#

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