Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 3caa0a47-de83-90d2-e063-6394a90a3436
Route
ORAL
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Sodium Starch Glycolate Type A Stearic Acid Titanium Dioxide Starch, Corn Crospovidone, Unspecified Hypromellose, Unspecified Microcrystalline Cellulose Povidone, Unspecified Propylene Glycol Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: ES Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

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:

  • • headache
  • • a cold
  • • arthritis
  • • muscular aches
  • • toothache
  • • premenstrual and 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 of age 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.

Questions Or Comments?

1-800-468-7746

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.

Inactive Ingredients (100 Ct)

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

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

Package Principal Package Label 25 Ct

EXCEDRIN

EXTRA STRENTH HEADACHE

Acetaminophen 250 mg,Aspirin 250 mg (NSAID)

and Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

25 CAPLETS

Packaged and Distributed by: Select Corporation, Carrollton TX

©2023 Haleon or licensor. Trademarks are owned by or licensed

to the Haleon group of companies.

Package/label Principal Display Panel (2ct)

EXCEDRIN

EXTRA STRENTH HEADACHE

Acetaminophen 250 mg,Aspirin 250 mg (NSAID)

and Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

2 CAPLETS

Packaged and Distributed by: Select Corporation, Carrollton TX

©2023 Haleon or licensor. Trademarks are owned by or licensed

to the Haleon group of companies.

Package / Label Principal Display Panel 50ct.

EXCEDRIN

EXTRA STRENTH HEADACHE

Acetaminophen 250 mg,Aspirin 250 mg (NSAID)

and Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

50

CAPLETS

Packaged and Distributed by: Select Corporation, Carrollton TX

©2023 Haleon or licensor. Trademarks are owned by or licensed

to the Haleon group of companies.

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 and 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 of age 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.

Questions Or Comments? (Questions or comments?)

1-800-468-7746

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.

Inactive Ingredients (100 Ct) (Inactive ingredients (100 ct))

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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. (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

Package Principal Package Label 25 Ct (Package Principal Package Label 25 ct)

EXCEDRIN

EXTRA STRENTH HEADACHE

Acetaminophen 250 mg,Aspirin 250 mg (NSAID)

and Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

25 CAPLETS

Packaged and Distributed by: Select Corporation, Carrollton TX

©2023 Haleon or licensor. Trademarks are owned by or licensed

to the Haleon group of companies.

Package/label Principal Display Panel (2ct) (Package/Label Principal Display Panel (2ct))

EXCEDRIN

EXTRA STRENTH HEADACHE

Acetaminophen 250 mg,Aspirin 250 mg (NSAID)

and Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

2 CAPLETS

Packaged and Distributed by: Select Corporation, Carrollton TX

©2023 Haleon or licensor. Trademarks are owned by or licensed

to the Haleon group of companies.

Package / Label Principal Display Panel 50ct.

EXCEDRIN

EXTRA STRENTH HEADACHE

Acetaminophen 250 mg,Aspirin 250 mg (NSAID)

and Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

50

CAPLETS

Packaged and Distributed by: Select Corporation, Carrollton TX

©2023 Haleon or licensor. Trademarks are owned by or licensed

to the Haleon group of companies.

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

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