CHILDRENS ACETAMINOPHEN- childrens acetaminophen suspension 
Pharmaceutical Associates, Inc.

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.

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Children's Acetaminophen Oral Suspension

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

WARNINGS

Liver warnings

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

• 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

Weight (lb)Age (yr)Dose (mL)*
Under 24Under 2 yearsask 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

*or as directed by a doctor

Other information

NDC 0121-0946-05: 5 mL unit dose cup, in a tray of ten cups.

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.

**This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Oral
***Gluten Free

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R06/21

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Delivers 5 mL
NDC 0121-0946-05

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

A0946050621

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

CHILDRENS ACETAMINOPHEN 
childrens acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0946
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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
Colorwhite (to off-white) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0946-303 in 1 CASE09/07/2021
110 in 1 TRAY
1NDC:0121-0946-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:0121-0946-0010 in 1 CASE09/07/2021
210 in 1 TRAY
2NDC:0121-0946-055 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 not finalpart34309/07/2021
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0946) , label(0121-0946)

Revised: 5/2022
Document Id: dff1f086-659e-c701-e053-2995a90a4175
Set id: 287d1a63-0197-423a-83a1-b40c474f7ac5
Version: 4
Effective Time: 20220526
 
Pharmaceutical Associates, Inc.