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:

NDC 0121-0657-05:  5 mL unit dose cup

NDC 0121-0657-00:   Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1314-11:  10.15 mL unit dose cup

NDC 0121-1314-00:   Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1971-21:  20.3 mL unit dose cup

NDC 0121-1971-00:   Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.

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

R10/20

Delivers 5 mL

NDC 0121-0657-05

Acetaminophen Oral Solution USP

160 mg/5 mL

ALCOHOL FREE

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F0657051020

[Image in the official label — see DailyMed source]

Delivers 10.15 mL

NDC 0121-1314-11

Acetaminophen Oral Solution USP

325 mg/10.15 mL

ALCOHOL FREE

Package Not Child-Resistant 

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F0657111020

[Image in the official label — see DailyMed source]

Delivers 20.3 mL

NDC 0121-1971-21

Acetaminophen Oral Solution USP

650 mg/20.3 mL

ALCOHOL FREE

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F0657211020

[Image in the official label — see DailyMed source]