ACETAMINOPHEN- acetaminophen solution 
PAI Holdings, LLC dba PAI Pharma

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Acetaminophen Oral Solution USP

Alcohol Free/Dye Free/Sugar Free
Grape Flavored

Active ingredient
(in each 5 mL)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

Uses

• for the temporary relief of minor aches and pains due to

• for the minor pain from arthritis
• and to reduce 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
  • taken with other drugs containing acetaminophen
  • adult has 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

Ask a doctor before use if the user
   •  has liver disease
   •  is a child with pain of arthritis

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

Stop use and ask a doctor if

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 over20 mL (640 mg) every 4 to 6 hours
not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age10 mL (320 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

■ Each 5 mL contains: sodium 6 mg

■ store at 20° to 25°C (68° to 77°F)

Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

Questions or comments?

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

Distributed by:

PAI Pharma
Greenville,SC 29605
www.paipharma.com
R05/25

PRINCIPAL DISPLAY PANEL - 5 mL Cup

Delivers 5 mL

NDC 0121-1047-05

Acetaminophen
Oral Solution USP
160 mg/5 mL

Pain Reliever/Fever Reducer

Alcohol Free/Dye Free/Sugar Free
Grape Flavored

Package Not Child-Resistant

Dist. by: PAI Pharma
GREENVILLE, SC 29605
See insert for drug facts

lidding for 5 mL Acetaminophen FN1047 cup
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1047-0010 in 1 CASE12/09/2025
110 in 1 TRAY
1NDC:0121-1047-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/09/2025
Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-1047)

Revised: 12/2025
Document Id: ba8d56c1-521e-490b-a83e-ebfa2d51bd8b
Set id: fac4e0c6-684f-45a1-99f2-de4de4017cc8
Version: 3
Effective Time: 20251211
 
PAI Holdings, LLC dba PAI Pharma