Acetaminophen

ACETAMINOPHEN160 mg

Pain reliever/fever reducer

temporarily relieves minor aches and pains due to:

• •headache
• •muscular aches
• •backache
• •minor pain of arthritis
• •the common cold
• •toothache
• •premenstrual and menstrual cramps

temporarily reduces fever

Label information

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

• ▪adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• ▪child takes more than 5 doses in 24 hours
• ▪taken with other drugs containing acetaminophen
• ▪adult has 3 or more alcoholic drinks every day while using this product

Label information

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:                        

• •skin reddening
• •blisters
• •rash

If a skin reaction occurs, stop use and seek medical help right away.

Label information

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
• •for more than 10 days for pain unless directed by a doctor
• •for more than 3 days for fever unless directed by a doctor
• •if you are allergic to acetaminophen or any of the inactive ingredients of this product

Label information

Ask a doctor before use if the user has liver disease

Label information

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

Stop use and ask a doctor if

• •symptoms do not improve
• •new symptoms occur
• •pain or fever persists or gets worse

Label information

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

Label information

Keep out of reach of children.

Label information

Overdose warning:  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 children even if you do not notice any signs or symptoms.

• ▪ do not take more than directed (see overdose warning)

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age	10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age	5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

■ Each 5 mL contains: sodium 2 mg

■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

■ keep tightly closed  ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

Overbagged with 5 x unit dose cups of 20.3 mL in each bag, NDC 55154-9449-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L53336120225

R10/20

NDC 55154-9449-5

ACETAMINOPHEN ORAL SOLUTION USP

650 mg / 20.3 mL

5 CUPS

[Image in the official label — see DailyMed source]