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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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
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)* |
|
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