CHILDRENS ACETAMINOPHEN 160 mg/5mL
CHILDRENS ACETAMINOPHEN ORAL · SUSPENSION · AARNA USA INC.
CHILDRENS ACETAMINOPHEN is a suspension containing childrens acetaminophen oral at 160 mg/5mL, taken oral. Manufactured by AARNA USA INC..
Key Facts
- Brand Name
- CHILDRENS ACETAMINOPHEN
- Generic Name
- CHILDRENS ACETAMINOPHEN ORAL
- NDC Code (Product)
82568-0010- Manufacturer
- AARNA USA INC.
- Strength
- 160 mg/5mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- M013
- Marketing Start
- 06/20/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
Dosage & Administration
Directions • 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 • 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)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL *or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Warnings
Warnings 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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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. • if your child has ever had an allergic reaction to this product or any of its ingredients 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) Stop use and ask a doctor if • pain gets worse or lasts more than 5 days • fever gets worse or lasts more tha…
Frequently Asked Questions
What is CHILDRENS ACETAMINOPHEN used for?
CHILDRENS ACETAMINOPHEN contains CHILDRENS ACETAMINOPHEN ORAL. It is a suspension taken oral. Consult your doctor for specific uses.
Is CHILDRENS ACETAMINOPHEN a controlled substance?
CHILDRENS ACETAMINOPHEN is not classified as a controlled substance by the DEA.
What is the generic name for CHILDRENS ACETAMINOPHEN?
The generic name for CHILDRENS ACETAMINOPHEN is CHILDRENS ACETAMINOPHEN ORAL. There are no other listed brand versions of CHILDRENS ACETAMINOPHEN ORAL.
What is the NDC code for CHILDRENS ACETAMINOPHEN 160 mg/5mL?
The NDC (National Drug Code) for CHILDRENS ACETAMINOPHEN 160 mg/5mL is 82568-0010, listed by AARNA USA INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)