Compare To Active Ingredients In Excedrin®

Compare To Active Ingredients In Excedrin®
SPL v2
SPL
SPL Set ID 50f72713-50f5-4bab-9e96-b9fa73c9df1f
Route
ORAL
Published
Effective Date 2025-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Acetylsalicylic Acid (65 mg) Caffeine
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Starch, Corn Sodium Starch Glycolate Type A Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 11 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-09

Description

Active ingredients (in each caplet)                                                          Purposes Acetaminophen USP, 250 mg...............................................................Pain reliever Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever Caffeine USP, 65 mg........................................................................Pain reliever aid *nonsteroidal anti-inflammatory drug


Medication Information

Description

Active ingredients (in each caplet)                                                          Purposes Acetaminophen USP, 250 mg...............................................................Pain reliever Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever Caffeine USP, 65 mg........................................................................Pain reliever aid *nonsteroidal anti-inflammatory drug

Uses
  • temporarily relieves minor aches and pains due to:
  • headache 
  • a cold
  • arthritis 
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Section 50566-9

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
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • any new symptoms occur. These could be signs of a serious condition
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for:
  • diabetes 
  • gout 
  • arthritis 
  • taking any other drug, or are under a doctor's care for any serious condition 
  • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer.
Section 50569-3

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
Section 53413-1

Questions and comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 Made in India Mfg. Lic. No.: G/25/1362

Issued: 09/2025

S-066



+This product is not manufactured or distributed by the owner of the registered trademark Excedrin® Extra Strength

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during 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.

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 take 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. Do not take more than 8 caplets in 24 hours.
  • children under 12 years: ask a doctor

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • close cap tightly after use
  • read all product information before using.
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.
Inactive Ingredients

Colloidal silicon dioxide , hypromellose, microcrystalline cellulose , polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label.principal Display Panel

EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine

250mg/250mg/65mg

NDC 57237-348-01

100 Caplets



Do Not Use If Printed Seal Under Cap Is Missing Or Damaged

Active ingredients (in each caplet)                                                          Purposes

Acetaminophen USP, 250 mg...............................................................Pain reliever

Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever

Caffeine USP, 65 mg........................................................................Pain reliever aid

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache 
  • a cold
  • arthritis 
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Section 50566-9 (50566-9)

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
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • any new symptoms occur. These could be signs of a serious condition
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for:
  • diabetes 
  • gout 
  • arthritis 
  • taking any other drug, or are under a doctor's care for any serious condition 
  • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer.
Section 50569-3 (50569-3)

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
Section 53413-1 (53413-1)

Questions and comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 Made in India Mfg. Lic. No.: G/25/1362

Issued: 09/2025

S-066



+This product is not manufactured or distributed by the owner of the registered trademark Excedrin® Extra Strength

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during 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.

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 take 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. Do not take more than 8 caplets in 24 hours.
  • children under 12 years: ask a doctor

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • close cap tightly after use
  • read all product information before using.
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.
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide , hypromellose, microcrystalline cellulose , polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine

250mg/250mg/65mg

NDC 57237-348-01

100 Caplets



Do Not Use If Printed Seal Under Cap Is Missing Or Damaged (DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED)

Active ingredients (in each caplet)                                                          Purposes

Acetaminophen USP, 250 mg...............................................................Pain reliever

Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever

Caffeine USP, 65 mg........................................................................Pain reliever aid

*nonsteroidal anti-inflammatory drug


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