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Acetaminophen, Aspirin and Caffeine

Dosage form
TABLET
Labeler
Rising Pharma Holdings, Inc.
Label updated
2025-10-06
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · ASPIRIN · CAFFEINE
View original label and images on DailyMed ↗
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED Drug Facts

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
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.

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.
Label information

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
Label information

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.
Label information

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
Label information

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.

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.

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.
Inactive ingredients

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

제조사 문의

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine
250mg/250mg/65mg

NDC 57237-348-01

100 Caplets

[Image in the official label — see DailyMed source]

DailyMed Set ID: 50f72713-50f5-4bab-9e96-b9fa73c9df1f · Version 2
NDC: 57237-348