[McNeil Consumer Healthcare Div McNeil-PPC, Inc]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph not final|
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- sore throat
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
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.
- 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 is allergic to acetaminophen or any of the inactive ingredients in this product
When using this product do not exceed recommended dose (see overdose warning)
- 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.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter; tsp = teaspoonful
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child's dose into the dosing cup
- 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 tsp) *|
|under 24||under 2 years||ask a doctor|
|24-35||2-3 years||5 mL (1 tsp)|
|36-47||4-5 years||7.5 mL (1½ tsp)|
|48-59||6-8 years||10 mL (2 tsp)|
|60-71||9-10 years||12.5 mL (2½ tsp)|
|72-95||11 years||15 mL (3 tsp)|
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- each 5 mL (1 tsp) contains: sodium 2 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
- see bottom panel for lot number and expiration date
anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
|Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)|