Drug Facts
a71074a6-cc19-4bb3-8c84-4e82a8906801
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever Pain reliever Pain reliever aid
Medication Information
Purpose
Pain reliever Pain reliever Pain reliever aid
Description
Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Uses
-
•temporarily relieves minor aches and pains due to:
-
oheadache
-
oa cold
-
oarthritis
-
omuscular aches
-
otoothache
-
opremenstrual & menstrual cramps
-
Purposes
Pain reliever
Pain reliever
Pain reliever aid
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 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.
Directions
-
•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
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.
Other Information
-
•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
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?
1-800-452-0051
Principal Display Panel
NDC 0067-2000-10
EXCEDRIN®
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
10 CAPLETS
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
©2015 GSK or its licensor.
Visit us at www.excedrin.com
46172146
Ask A Doctor Before Use If
-
•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
Keep Out of Reach of Children.
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.
Active Ingredient (in Each Caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Ask A Doctor Or Pharmacist Before Use If 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
Structured Label Content
Uses
-
•temporarily relieves minor aches and pains due to:
-
oheadache
-
oa cold
-
oarthritis
-
omuscular aches
-
otoothache
-
opremenstrual & menstrual cramps
-
Purposes
Pain reliever
Pain reliever
Pain reliever aid
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 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.
Directions
-
•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
Do Not Use (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.
Other Information (Other information)
-
•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 ingredients)
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? (Questions or comments?)
1-800-452-0051
Principal Display Panel
NDC 0067-2000-10
EXCEDRIN®
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
10 CAPLETS
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
©2015 GSK or its licensor.
Visit us at www.excedrin.com
46172146
Ask A Doctor Before Use If (Ask a doctor before use if)
-
•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
Keep Out of Reach of Children. (Keep out of reach of children.)
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.
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if 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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:59.845362 · Updated: 2026-03-14T23:02:50.389879