Slideshows Images Quizzes

Tylenol

Last reviewed on RxList: 12/4/2017
Drug Description

Tylenol® 325 mg
(acetaminophen) Regular Strength

DESCRIPTION

Active Ingredient

Acetaminophen Regular Strength

Drug Facts

Active Ingredient (in each caplet) Acetaminophen 325 mg

For Consumers

What are the possible side effects of acetaminophen?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have a serious side effect such as:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Indications & Dosage

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 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.

Overdosage & 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
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.

FDA Logo

Report Problems to the Food and Drug Administration

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.

Health Solutions From Our Sponsors