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Childrens Acetaminophen by Cardinal Health

Medically reviewed on January 5, 2018

Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Cardinal Health
NDC Code: 55154-1586

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.

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 = 1 teaspoonful)

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)
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
shake cups well before using

Other Information
each 5 mL (1 tsp) contains: sodium 3 mg
store at 20°- 25°C (68°-77°F)
see individual label or shipper label 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 -5 mL per unit dose cups per bag, NDC 55154-1586-5

Distributed By

Perrigo Company

Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
South Beloit, IL 61080

Repackaged By:

Cardinal Health

Zanesville, OH 43701

LI 950
Rev. 08/15

L49929700914

Principal Display Panel

Children's Acetaminophen

Oral Suspension 160 mg/5 mL

5 x 5 mL UNIT DOSE CUPS

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1586(NDC:68094-587)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylparaben 
CALCIUM SULFATE, UNSPECIFIED FORM 
carrageenan 
D&C red no. 33 
FD&C blue no. 1 
glycerin 
high fructose corn syrup 
MICROCRYSTALLINE CELLULOSE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sodium phosphate, tribasic 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1586-55 CUP, UNIT-DOSE in 1 BAG
15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/11/2014
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-1586)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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