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Acetaminophen 250mg, Aspirin 250mg and Caffeine 65mg

OTC Oral RxCUI 308297
Contents

Overview

Active ingredient
Caffeine, Aspirin, Acetaminophen
Established class
Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism class
Cyclooxygenase Inhibitors
Physiologic effect
Central Nervous System Stimulation; Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical structure
Xanthines; Anti-Inflammatory Agents, Non-Steroidal
Route
Oral
Label date
2026-05-18

Indications and usage

Uses Temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps

Purpose

Pain reliever Pain reliever Pain reliever aid

Dosage and administration

Directions

  • do not use more than directed (see overdose warning)
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours
  • children under 12 years: ask a doctor

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 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 geltabs 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 occasional rapid heartbeat.

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

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

Ask a doctor or pharmacist before use if

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

Stop use and ask a doctor if

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.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health 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.

Active ingredient (label)

(in each softgel) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Inactive ingredients

s corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin

Keep out of reach of children

of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.