CHILDRENS ACETAMINOPHEN- acetaminophen suspension 
PAI Holdings, LLC

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Children's Acetaminophen Oral Suspension
Ibuprofen Free/Alcohol Free/Aspirin Free

Drug Facts

Active ingredient                                                                                 
(in each 5 mL)  

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

Warnings

Liver warning: This product contains contains acetaminophen. Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has liver disease.

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

When using this product, do not exceed the recommended dose (see overdose warning)

Stop use and ask a doctor if:
• pain gets worse or lasts more than 5 days
• 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.

Keep out of the reach of children.

Overdose warning: 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 sign or symptoms

Directions

*
or as directed by a doctor
Weight (lbs)Age (yr)Dose (mL) *
Under 24Under 2Ask a doctor
24-352-3 years5 mL 
36-474-5 years7.5 mL 
48-596-8 years10 mL 
60-719-10 years12.5 mL 
72-9511 years15 mL 

Other information

NDC 0121-1781-05:  5 mL unit dose cup, in a tray of ten cups

Inactive ingredients

Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R09/20

PRINCIPAL DISPLAY PANEL - 5 mL Cup

Delivers 5 mL

NDC 0121-1781-05

CHILDREN'S ACETAMINOPHEN  ORAL SUSPENSION

160 mg per 5 mL

Ibuprofen Free/ Alcohol Free / Aspirin Free

SHAKE WELL BEFORE USING

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

5 mL Unit Dose Cup Label
CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1781
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
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1781-0010 in 1 CASE09/17/2007
110 in 1 TRAY
1NDC:0121-1781-055 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 DrugM01309/17/2007
Labeler - PAI Holdings, LLC (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-1781)

Revised: 1/2023
Document Id: 86d6208e-7b1a-4837-8a92-61ea615cda32
Set id: 46d9d8cd-e3db-492c-9386-7e8255beff64
Version: 11
Effective Time: 20230131
 
PAI Holdings, LLC