Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

Find Lowest Prices on Tylenol® 325 mg (acetaminophen) Regular Strength 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

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.

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.

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.