Excedrin® Extra Strength

Excedrin® Extra Strength
SPL v1
SPL
SPL Set ID 60af6b21-9dc2-461e-a9bd-28d8e75cecb5
Route
ORAL
Published
Effective Date 2022-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Benzoic Acid Carnauba Wax Fd&c Blue No. 1 Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Light Mineral Oil Microcrystalline Cellulose Polysorbate 20 Povidone, Unspecified Propylene Glycol Dimethicone Sorbitan Monolaurate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: E Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-23

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

Advanced Ingredient Data


Raw Label Data

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