Childrens Acetaminophen by R3 Pharmaceuticals, LLC
Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: R3 Pharmaceuticals, LLC
NDC Code: 59999-001
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.
Acetaminophen 160 mg
Pain reliever/fever reducer
- 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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)
- 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.
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 even if you do not notice any signs or symptoms.
- do not give more than directed (see Liver and overdose warning)
- shake well before use
- this product does not contain directions or complete warnings for adult use
- use only with enclosed dosing cup
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- find right dose on chart below. If possible, use weight to dose, otherwise; use age.
|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|
- each teaspoon contains: sodium 3 mg
- store at 20°-25°C (68°-77°F)
anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution
Distributed by: R3 Pharmaceuticals,LLC
Canton, MS 39046
SEE NEW WARNINGS INFORMATION
*Compare to the active ingredient in
Children's Tylenol® Oral Suspension*
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
4 FL OZ (118 mL)
|Labeler - R3 Pharmaceuticals, LLC (078888843)|
Medically reviewed on Sep 25, 2018