FDA Label for Acetaminophen

Other

Drug Facts

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

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

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.

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

Ask A Doctor Before Use If You Have

• •liver disease

Ask A Doctor Or Pharmacist Before Use If

• •you are taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

Directions

• •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

Other Information

■ sodium content: 2 mg/5 mL 

■ 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:

Available overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5

Inactive Ingredients

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

Questions Or Comments?

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

Manufactured By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L53336120617

R01/17

Principal Display Panel

Acetaminophen Oral Solution USP

650 mg/ 20.3 mL

5 Cups