Pain and Fever by Accudial Pharmaceutical, Inc.
Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-131
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.
Pain & Fever
Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
temporarily reduces fever
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.
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 the child has liver disease.
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.
Do not exceed recommended dose.
- 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 the 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.
- shake well before using
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
- to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
- specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
|Age (yr)||Dose (mL or tsp)|
|under 2 years||ask a doctor|
|2-3 years||5 mL or 1 tsp.|
|4-5 years||7.5 mL or 1½ tsp.|
|6-8 years||10 mL or 2 tsp.|
|9-10 years||12.5 mL or 2½ tsp.|
|11 years||15 mL or 3 tsp.|
- each teaspoon contains: sodium 2 mg
- do not use if inner foil seal is broken or missing
- store between 20°-25°C (68°-77°F)
- see bottom panel for lot number and expiration date
artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
ROTATING DOSING LABEL
ACCURATE DOSING BY WEIGHT
For Ages 2 to under 12
Alcohol Free • Aspirin Free • Ibuprofen Free
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
|PAIN AND FEVER
|Labeler - Accudial Pharmaceutical, Inc. (831999201)|
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.