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Acetaminophen by Pharmaceutical Associates, Inc.

Dosage form: solution
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0657

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 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

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
  • do not take more than directed (see overdose warning)
agedose
adults and children 12 years of age and over20.3 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 age10.15 mL (325 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children under 2 years of ageconsult 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:  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.

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

R01/17

PRINCIPAL DISPLAY PANEL - 20 mL Cup

Delivers 20.3 mL

NDC 0121-1971-21

A CETAMINOPHEN

O RAL S OLUTION USP

650 mg/20.3 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F06572102

PRINCIPAL DISPLAY PANEL - 10 mL Cup

Delivers 10.15 mL

NDC 0121-1314-11

A CETAMINOPHEN

O RAL S OLUTION USP

325 mg/10.15 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F06571102

PRINCIPAL DISPLAY PANEL - 5 mL Cup

Delivers 5 mL

NDC 0121-0657-05

A CETAMINOPHEN

O RAL S OLUTION USP

160 mg/5 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A06570500

ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0657
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0657-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-0657-055 mL in 1 CUP, UNIT-DOSE
2NDC:0121-0657-1110 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
210.15 mL in 1 CUP, UNIT-DOSE
3NDC:0121-0657-2110 TRAY in 1 CASE
310 CUP, UNIT-DOSE in 1 TRAY
320.3 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2007
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1314
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1314-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-1314-1110.15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2007
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1971
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1971-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-1971-2120.3 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2007
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0657, 0121-1314, 0121-1971)

 
Pharmaceutical Associates, Inc.

← See all Acetaminophen brands

Medically reviewed on Mar 21, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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