Usual Adult Dose for Analgesic/Antipyretic

2 tablets orally every 6 hours
Maximum dose: 8 tablets in 24 hours

Each tablet contains: acetaminophen 250 mg/aspirin 250 mg/caffeine 65 mg

Comments:

• This combination drug should not be taken with any other drug containing acetaminophen.
• Patients should limit their caffeine use while taking this drug.

Uses: For the temporary relief of minor aches and pains due to headache, cold, arthritis, muscular aches, toothache, or premenstrual or menstrual cramps.

Usual Pediatric Dose for Analgesic/Antipyretic

12 years or older:

2 tablets orally every 6 hours
Maximum dose: 8 tablets in 24 hours

Each tablet contains: acetaminophen 250 mg/aspirin 250 mg/caffeine 65 mg

Comments:

• Pediatric patients recovering from the chicken pox or flu-like symptoms should not use this product.
• This combination drug should not be taken with any other drug containing acetaminophen.
• Patients should limit their caffeine use while taking this drug.

Uses: For the temporary relief of minor aches and pains due to headache, cold, arthritis, muscular aches, toothache, or premenstrual or menstrual cramps.

Renal Dose Adjustments

Use with caution; generally, aspirin is not recommended for use in severe renal impairment (CrCl less than 10 mL/minute) due to the potential for increased risk of salicylate toxicity

Liver Dose Adjustments

Use with caution; chronic use of acetaminophen is not recommended in patients with liver disease and aspirin is not recommended in patients with severe hepatic impairment due to increased risk of clinically significant bleeding and other adverse effects

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substances or any other pain reliever/fever reducer
• Concomitantly with any other drug containing acetaminophen (prescription or nonprescription)

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions

Dialysis

Data not available

Other Comments

Administration advice:
Tablets: Take orally with a full glass of water

General:

• Pediatric patients recovering from the chicken pox or flu-like symptoms should not use this product due to risk of Reye's syndrome; changes in behavior with nausea and vomiting could be early signs of Reye's syndrome.
• Patients taking this combination product should not take other acetaminophen-containing products, NSAID-containing products (including aspirin), and limit their use of caffeine-containing medications, foods, and beverages.

Monitoring:

• Monitor for signs and symptoms of bleeding

Patient advice:

• Patients should be instructed to read the product labeling.
• Patients should be instructed not to take any other drugs containing acetaminophen while taking this drug; if they suspect they have taken too much acetaminophen, they should contact a healthcare professional even if they feel fine.
• Patients should understand that this product is for occasional use; they should be advised to contact their healthcare provider if their symptoms worsen while using this product.
• Patients should be advised to avoid caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, or palpitations.
• Patients should be instructed to seek immediate medical assistance if they have an allergic reaction.
• Patients should contact their healthcare professional promptly if they experience signs of stomach bleeding such as vomiting blood, black or bloody stools, or stomach pain that does not get better.