leader pain reliever
- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each 5 mL = 1 teaspoon)
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
Active ingredient (in each 5 mL = 1 teaspoon)
Acetaminophen 160 mg
Pain reliever/fever reducer
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- sore throat
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
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.
Ask a doctor before use if your child has
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.
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.
- do not give more than directed (see Liver warning)
- shake well before using
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- this product does not contain directions or complete warnings for adult use
|Weight(lb)||Age(yr)||Dose (tsp or mL)|
|under 24||under 2 years||ask a doctor|
|24-35||2–3 years||1 tsp or 5 mL|
|36–47||4–5 years||1 1/2 tsp or 7.5 mL|
|48–59||6–8 years||2 tsp or 10 mL|
|60-71||9–10 years||2 1/2 tsp or 12.5 mL|
|72-95||11 years||3 tsp or 15 mL|
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- each teaspoon contains: sodium 3 mg
- store at 20°-25°C (68°-77°F)
- do not use if printed neckband is broken or missing
anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution
Questions or comments?
Principal Display Panel
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Compare to Children’s Tylenol® Oral Suspension active ingredient
For Ages 2 - 11
Acetaminophen Oral Suspension
80 mg per 1/2 teaspoon (160 mg per 5 mL)
Bubble Gum Flavor
leader pain reliever