CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension 
PAI Holdings, LLC

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Childrens Acetaminophen Oral Suspension

Drug Facts

Active ingredient

(in each 5 mL)
Acetaminophen 160 mg

Purpose

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses temporarily:

• the common cold • flu • headache • sore throat • toothache

Warnings

Liver warning: This product 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

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 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 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

Attention: For Single-Dose Cups, the entire dose should be taken.

Weight (lb)  Age (yr)Dose (mL)*
under 24               under 2 years         ask a doctor
24-35                   2-3 years                5 mL
36-47                   4-5 years                7.5 mL
48-59                   6-8 years                10 mL
60-71                   9-10 years              12.5 mL
72-95                   11 years                 15 mL

*or as directed by a doctor

Other information

   NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

   NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
   NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients: acesulfame K, butylparaben, citric acid, 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

R01/22

Principal Display Panel

Delivers 5 mL

NDC 0121-0966-05

DYE FREE/GRAPE FLAVOR

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

SEE INSERT

Children's Acetaminophen Oral Suspension
CHILDRENS ACETAMINOPHEN ORAL SUSPENSION 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0966
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)  
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
Colorwhite (to off-white appearance) Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0966-943 in 1 CASE03/09/2022
110 in 1 TRAY
1NDC:0121-0966-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:0121-0966-0010 in 1 CASE03/09/2022
210 in 1 TRAY
2NDC:0121-0966-055 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 DrugM01303/09/2022
Labeler - PAI Holdings, LLC (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693label(0121-0966) , manufacture(0121-0966)

Revised: 12/2023
Document Id: e24e0f6b-f066-48ef-a477-da9db822e800
Set id: a69fca9d-c0a0-4321-bf03-5c8e99cc07cc
Version: 5
Effective Time: 20231204
 
PAI Holdings, LLC