Tylenol

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/11/2022

Drug Summary

What Is Tylenol?

Tylenol (acetaminophen) is an analgesic (pain reliever) and antipyretic (fever reducer) used for treating pain and fever associated with many conditions. Tylenol is available in generic form and over-the-counter (OTC).

What Are Side Effects of Tylenol?

Side effects of Tylenol include:

  • nausea,
  • stomach pain,
  • loss of appetite,
  • itching,
  • rash,
  • headache,
  • dark urine,
  • clay-colored stools,
  • or jaundice (yellowing of skin or eyes).

Get medical help right away if you notice symptoms of a rare serious allergic reaction to Tylenol, including:

  • rash,
  • itching/swelling (especially of the face/tongue/throat),
  • severe dizziness,
  • or trouble breathing.

Dosage for Tylenol

The oral dose of Tylenol for adults is 325 to 650 mg every 4 to 6 hours. The maximum daily dose is 4 grams.

What Drugs, Substances, or Supplements Interact with Tylenol?

Tylenol may interact with antibiotics, antifungals, sulfa drugs, tuberculosis medicines, birth control pills or hormone replacement therapy, blood pressure medication, cancer medications, cholesterol-lowering medications, gout or arthritis medications (including gold injections), HIV/AIDS medications, medicines to treat psychiatric disorders, nonsteroidal anti-inflammatory drugs (NSAIDs), or seizure medications. Tell your doctor all medications and supplements you use.

Tylenol During Pregnancy and Breastfeeding

Tylenol is used in all stages of pregnancy and is the drug of choice for short-term treatment of fever and minor pain during pregnancy. Although Tylenol is excreted in breast milk in small quantities, it is safe to be used by nursing mothers.

Additional Information

Our Tylenol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Drug Description

DESCRIPTION

Active Ingredient

Acetaminophen Regular Strength

Drug Facts

Active Ingredient (in each caplet) Acetaminophen 325 mg

Indications

INDICATIONS

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

This package is intended for institutional use only. Keep this and all drugs out of the reach of children.

Uses

For Hospital and Government Use Only

Temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, and temporarily reduces fever.

Dosage

DOSAGE AND ADMINISTRATION

Directions

Directions do not take more than directed (see OVERDOSE WARNING)

adults and children 12
years and over
  • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 12 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 caplet every 4 to 6 hours while symptoms last
  • do not take more than 5 caplets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
1children under 6 years do not use this adult product in children under 6 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

HOW SUPPLIED

Inactive ingredients

Carnauba wax, castor oil, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Storage

Store between 20-25°C (68-77°F)

Other

See New WARNINGS Information

Distributed By: Mcneil Consumer Healthcare, Division Of Mcneil - ppc, Inc., Fort Washington, PA 19034 USA

Side Effects & Drug Interactions

SIDE EFFECTS

No information provided.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

Do not use if pouch is opened

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking blood thinning drug warfarin.

PRECAUTIONS

No information provided.

Overdose & Contraindications

OVERDOSE

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice an signs or symptoms.

CONTRAINDICATIONS

No information provided.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

No information provided.

Medication Guide

PATIENT INFORMATION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking blood thinning drug warfarin.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.