Dosage form: solution
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0840
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, USP 160 mg
Pain reliever/ fever reducer
- temporarily reduces fever
- temporarily 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.
- 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
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.
Overdose warning: 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)
- use an accurate measuring device to administer this medication
- mL = milliliter; tsp = teaspoonful
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- if needed, 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|
5 mL (1 tsp)
|36-47||4-5 years||7.5 mL (1 ½ tsp)|
10 mL (2 tsp)
|12.5 mL (2 ½ tsp)|
|72-95||11 years||15 mL (3 tsp)|
- each 5mL (1 tsp) contains: sodium 2 mg
- store at 15º to 30ºC (59º to 86ºF)
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
D&C red #33, FD&C blue #1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose
Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811
Rev. 1/15 R10
|Labeler - Qualitest Pharmaceuticals (011103059)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.