DrugCite

ACETAMINOPHEN - acetaminophen solution 
Pharmaceutical Associates, Inc.

Acetaminophen
Oral Solution USP
Alcohol Free

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

Warnings

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
  • adult has 3 or more alcoholic drinks everyday while using this product

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask a doctor before use if the user has liver disease.

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults and children
  • 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.

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

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:
    NDC 0121-0657-05 (unit dose cups of 5 mL, 10 × 10's), NDC 0121-0657-11 (unit dose cups of 10.15 mL, 10 × 10's), and NDC 0121-0657-21 (unit dose cups of 20.3 mL, 10 × 10's).

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.

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R04/10

PRINCIPAL DISPLAY PANEL - 5 mL Cup

Delivers 5 mL

NDC 0121-0657-05

ACETAMINOPHEN

ORAL SOLUTION USP

160 mg/5 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A06570500

Principal Display Panel - 5 mL Cup

ACETAMINOPHEN 
acetaminophen  solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0121-0657
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
FD&C RED NO. 40  
GLYCERIN  
POLYETHYLENE GLYCOLS  
PROPYLENE GLYCOL  
WATER  
SODIUM BENZOATE  
SODIUM CITRATE  
SORBITOL  
SUCROSE  
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0121-0657-05 10  In 1 CASE contains a TRAY
1 10  In 1 TRAY This package is contained within the CASE (0121-0657-05) and contains a CUP, UNIT-DOSE
1 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0657-05)
2 0121-0657-11 10  In 1 CASE contains a TRAY
2 10  In 1 TRAY This package is contained within the CASE (0121-0657-11) and contains a CUP, UNIT-DOSE
2 10.15 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0657-11)
3 0121-0657-21 10  In 1 CASE contains a TRAY
3 10  In 1 TRAY This package is contained within the CASE (0121-0657-21) and contains a CUP, UNIT-DOSE
3 20.3 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0657-21)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 08/01/2023

Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
Name Address ID/FEI Operations
Pharmaceutical Associates, Inc. 097630693 MANUFACTURE
Revised: 07/2012Pharmaceutical Associates, Inc.