CHILDRENS ACETAMINOPHEN- acetaminophen suspension 
Cardinal Health

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

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:

the common cold
flu
headaches
sore throat
immunizations
toothaches
reduces fever

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

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 5 days
fever gets worse or lasts for more than 3 days
sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting

Keep out of reach of children.

Directions

Use as directed per healthcare professional.
do not use more than directed (see overdose warning)
shake cups well before using
repeat dose every 4 hours, if needed
do not use more than 5 times in 24 hours

Other Information

each teaspoon contains: sodium 3 mg
store at room temperature 15° - 30°C (59° - 86°F)
This product is not the same concentration as Infant's Drops. Use as directed per healthcare professional.
see individual label or shipper label for lot number and expiration date

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

Children's ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

5 x 5 mL UNIT DOSE CUPS

Bag Label
CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1583(NDC:68094-593)
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
butylparaben (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
carrageenan (UNII: 5C69YCD2YJ)  
citric acid monohydrate (UNII: 2968PHW8QP)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
glycerin (UNII: PDC6A3C0OX)  
high fructose corn syrup (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1583-55 in 1 BAG10/25/200503/31/2015
15 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 finalpart34310/25/200503/31/2015
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-1583)

Revised: 12/2017
 
Cardinal Health