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

Grape Flavor

80 mg/2.5 mL  160 mg/5 mL  325 mg/10.15 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
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

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 has ever had an allergic reaction to this product or any of its ingredients

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 even if you do not notice any signs or symptoms.

Directions

use as directed per healthcare professional
this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
shake cups well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise use age.
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL)*
*
or as directed by a doctor

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

Other information

each 5 mL contains: sodium 3 mg
store at 20-25°C (68-77°F)
see individual label or shipper for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

Overbagged with 5 x 5 mL unit dose cups per bag, NDC 55154-1586-5

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

Distributed By:

Cardinal Health

Dublin, OH 43017

LI950   Rev. 03/17

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

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:55154-1586(NDC:68094-587)
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
anhydrous citric acid (UNII: XF417D3PSL)  
butylparaben (UNII: 3QPI1U3FV8)  
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
carrageenan (UNII: 5C69YCD2YJ)  
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)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sodium phosphate, tribasic (UNII: A752Q30A6X)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1586-55 in 1 BAG04/11/201408/31/2021
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 finalpart34304/11/201408/31/2021
Labeler - Cardinal Health (603638201)

Revised: 5/2020
 
Cardinal Health