Excedrin® Extra Strength
60af6b21-9dc2-461e-a9bd-28d8e75cecb5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual & menstrual cramps
Section 42229-5
Drug Facts
Section 50565-1
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.
Section 53414-9
If pregnant or breast-feeding, 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.
Section 55105-1
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Aspirin 250 mg (NSAID nonsteroidal anti-inflammatory drug ) |
Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
Directions
- 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 |
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
Allergy Alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
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
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.
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.
Other Information
- store at 20°-25°C (68°-77°F)
- read all product information before using. Keep this card for important information.
Inactive Ingredients
benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcelluose, 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
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
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
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 occur
These could be signs of a serious condition
Principal Display Panel 2 Caplet Pouch Packet
EXCEDRIN®
EXTRA
STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
1 Packet of 2 Caplets
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:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual & menstrual cramps
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
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.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, 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.
Section 55105-1 (55105-1)
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Aspirin 250 mg (NSAID nonsteroidal anti-inflammatory drug ) |
Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
Directions
- 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 |
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
Allergy Alert (Allergy alert)
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
Liver Warning (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
Reye's Syndrome (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.
Caffeine Warning (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.
Other Information (Other information)
- store at 20°-25°C (68°-77°F)
- read all product information before using. Keep this card for important information.
Inactive Ingredients (Inactive ingredients)
benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcelluose, 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
Stomach Bleeding Warning (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
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
Stop Use and Ask A Doctor If (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 occur
These could be signs of a serious condition
Principal Display Panel 2 Caplet Pouch Packet (PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Packet)
EXCEDRIN®
EXTRA
STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
1 Packet of 2 Caplets
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
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Source: dailymed · Ingested: 2026-02-15T12:00:11.342515 · Updated: 2026-03-14T23:00:32.199749