CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION

CHILDRENS ACETAMINOPHEN - acetaminophen suspension 
Precision Dose Inc.

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CHILDREN'S ACETAMINOPHEN
ORAL SUSPENSION

160 mg/5 mL
325 mg/10.15 mL
650 mg/20.3 mL

Grape Flavor

For Hospital Use Only

Drug Facts

Active Ingredient
(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Uses

Temporarily relieves minor aches and pains due to:

Warnings

Overdose warning

Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Do not use with any other product containing acetaminophen.

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, carrageenan, citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol

Alcohol Free, Aspirin Free, Ibuprofen Free

How Supplied

NDC 68094-593-58
5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-593-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-593-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-614-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-650-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper

Mfg. By: Perrigo
515 Eastern Avenue
Allegan, MI 49010

Pkg. By: Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

LI806
Rev. 02/10

PRINCIPAL DISPLAY PANEL - 150 mg/5 mL Cup Lid

NDC 68094-593-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 150 mg/5 mL Cup Lid

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label

NDC# 68094-593-58

Children's ACETAMINOPHEN Oral Suspension

160 mg/5 mL  Delivers 5 mL
Alcohol Free Aspirin Free Ibuprofen Free
Each 5 mL contains Sodium 3 mg
Store at 15°-30°C (59°-86°F)
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
LSY 595 Rev 1105

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 325 mg/10.15 mL Cup Lid

NDC 68094-614-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
325 mg/10.15 mL

Delivers 10.15 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Ibuprofen Free

Store at Room Temp (59°-86°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 325 mg/10.15 mL

PRINCIPAL DISPLAY PANEL - 650 mg/20.3 mL Cup Lid

NDC 68094-650-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
650 mg/20.3 mL

Delivers 20.3 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Ibuprofen Free

Store at Room Temp (59°-86°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 650 mg/20.3 mL Cup Lid

CHILDRENS ACETAMINOPHEN 
acetaminophen   suspension
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)68094-593 (0113-0105)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Butylparaben 
carboxymethylcellulose sodium 
carrageenan 
citric acid monohydrate 
glycerin 
D&C red no. 33 
FD&C blue no. 1 
high fructose corn syrup 
cellulose, microcrystalline 
propylene glycol 
water 
sodium benzoate 
sorbitol 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168094-593-623 TRAY In 1 CASEcontains a TRAY
110 CUP In 1 TRAYThis package is contained within the CASE (68094-593-62) and contains a CUP, UNIT-DOSE (68094-593-59)
168094-593-595 mL In 1 CUP, UNIT-DOSEThis package is contained within a TRAY and a CASE (68094-593-62)
268094-593-6110 TRAY In 1 CASEcontains a TRAY
210 CUP In 1 TRAYThis package is contained within the CASE (68094-593-61) and contains a CUP, UNIT-DOSE (68094-593-59)
268094-593-595 mL In 1 CUP, UNIT-DOSEThis package is contained within a TRAY and a CASE (68094-593-61)
368094-593-585 BAG In 1 CASEcontains a BAG
310 SYRINGE In 1 BAGThis package is contained within the CASE (68094-593-58) and contains a SYRINGE, PLASTIC
35 mL In 1 SYRINGE, PLASTICThis package is contained within a BAG and a CASE (68094-593-58)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/25/2005

CHILDRENS ACETAMINOPHEN 
acetaminophen   suspension
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)68094-614 (0113-0105)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg  in 10.15 mL
Inactive Ingredients
Ingredient NameStrength
Butylparaben 
carboxymethylcellulose sodium 
carrageenan 
citric acid monohydrate 
glycerin 
D&C red no. 33 
FD&C blue no. 1 
high fructose corn syrup 
cellulose, microcrystalline 
propylene glycol 
water 
sodium benzoate 
sorbitol 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168094-614-623 TRAY In 1 CASEcontains a TRAY
110 CUP In 1 TRAYThis package is contained within the CASE (68094-614-62) and contains a CUP, UNIT-DOSE (68094-614-59)
168094-614-5910.15 mL In 1 CUP, UNIT-DOSEThis package is contained within a TRAY and a CASE (68094-614-62)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/21/2008

CHILDRENS ACETAMINOPHEN 
acetaminophen   suspension
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)68094-650 (0113-0105)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg  in 20.3 mL
Inactive Ingredients
Ingredient NameStrength
Butylparaben 
carboxymethylcellulose sodium 
carrageenan 
citric acid monohydrate 
glycerin 
D&C red no. 33 
FD&C blue no. 1 
high fructose corn syrup 
cellulose, microcrystalline 
propylene glycol 
water 
sodium benzoate 
sorbitol 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168094-650-623 TRAY In 1 CASEcontains a TRAY
110 CUP In 1 TRAYThis package is contained within the CASE (68094-650-62) and contains a CUP, UNIT-DOSE (68094-650-59)
168094-650-5920.3 mL In 1 CUP, UNIT-DOSEThis package is contained within a TRAY and a CASE (68094-650-62)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/21/2008

Labeler - Precision Dose Inc. (035886746)
Revised: 01/2011Precision Dose Inc.