Acetaminophen, aspirin and salicylamide

Acetaminophen, aspirin and salicylamide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acetaminophen, aspirin and salicylamide is an analgesic that is FDA approved for the treatment of temporarily relieves pain dut to headache, muscular aches, cold, flu, fever. Common adverse reactions include hypersensitivity.

• Temporarily relieves pain dut to: headache, muscular aches, cold, flu.
• Temporarily reduces fever.
• Adults: Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
• Children under 12 years, ask a doctor

There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen, aspirin and salicylamide in adult patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetaminophen, aspirin and salicylamide in adult patients.

There is limited information regarding Acetaminophen, aspirin and salicylamide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen, aspirin and salicylamide in pediatric patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetaminophen, aspirin and salicylamide in pediatric patients.

There is limited information regarding Acetaminophen, aspirin and salicylamide Contraindications in the drug label.

• Liver Warning: This product contains acetaminophen. Severe liver damage

• May occur if you take:
• More than 8 tablets in 24 hours
• With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 3 or more alcoholic drinks every day while using this product

• Do not use:

• With any other product containing acetaminophen this will provide more

than the recommended dose (overdose) of acetaminophen and could

• Cause serious health concerns.

• For more than 10 days for pain unless directed by a doctor.
• For more than 3 days for fever unless directed by a doctor.
• When using this product do not exceed recommended dose.

• Stop use and ask a doctor if:

• Symptoms do not improve.
• Pain or fever persists or gets worse.
• New symptoms occur.
• Redness or swelling is present.

There is limited information regarding Acetaminophen, aspirin and salicylamide Clinical Trials Experience in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Postmarketing Experience in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Drug Interactions in the drug label.

Pregnancy Category (FDA): There is no FDA guidance on usage of Acetaminophen, aspirin and salicylamide in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetaminophen, aspirin and salicylamide in women who are pregnant.

There is no FDA guidance on use of Acetaminophen, aspirin and salicylamide during labor and delivery.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in women who are nursing.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in pediatric settings.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in geriatric settings.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide with respect to specific gender populations.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide with respect to specific racial populations.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in patients with renal impairment.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in patients with hepatic impairment.

There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in women of reproductive potentials and males.

There is no FDA guidance one the use of Acetaminophen, aspirin and salicylamide in patients who are immunocompromised.

• Oral

There is limited information regarding Acetaminophen, aspirin and salicylamide Monitoring in the drug label.

There is limited information regarding the compatibility of Acetaminophen, aspirin and salicylamide and IV administrations.

There is limited information regarding Acetaminophen, aspirin and salicylamide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

There is limited information regarding Acetaminophen, aspirin and salicylamide Pharmacology in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Mechanism of Action in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Structure in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Pharmacodynamics in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Pharmacokinetics in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Nonclinical Toxicology in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Clinical Studies in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide How Supplied in the drug label.

There is limited information regarding Acetaminophen, aspirin and salicylamide Storage in the drug label.

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There is limited information regarding Acetaminophen, aspirin and salicylamide Patient Counseling Information in the drug label.

Alcohol-Acetaminophen, aspirin and salicylamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

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There is limited information regarding Acetaminophen, aspirin and salicylamide Look-Alike Drug Names in the drug label.

The contents of this FDA label are provided by the National Library of Medicine.

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