Tylenol

What is Tylenol and how is it used?

Tylenol is an over-the-counter (OTC) medicine used to treat reduce symptoms of pain and as a fever reducer. Tylenol may be used alone or with other medications.

Tylenol belongs to a class of drugs called Analgesics, Other.

What are the possible side effects of Tylenol?

Tylenol may cause serious side effects including:

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

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Tylenol include:

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

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tylenol. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Active Ingredient

Acetaminophen Regular Strength

Drug Facts

Active Ingredient (in each caplet) Acetaminophen 325 mg

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

No information provided.

DRUG INTERACTIONS

No information provided.

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

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

No information provided.

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.