CareOne Infants Acetaminophen 160 mg/5mL

Acetaminophen · SUSPENSION · American Sales Company

No Recall HistoryCurrently in Shortage

Plain English

CareOne Infants Acetaminophen is a suspension containing acetaminophen at 160 mg/5mL, taken oral. Manufactured by American Sales Company.

Key Facts

Brand Name: CareOne Infants Acetaminophen
Generic Name: Acetaminophen
NDC Code (Product): 41520-363
Manufacturer: American Sales Company
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 12/14/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports

fatigue20,433 reports

drug ineffective18,154 reports

pain18,105 reports

nausea17,623 reports

headache16,713 reports

toxicity to various agents15,538 reports

dyspnoea14,576 reports

arthralgia14,308 reports

pyrexia14,269 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle. • pull yellow part of syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL * or as directed by a doctor Attention: use only enclosed syringe 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 CareOne Infants Acetaminophen used for?

CareOne Infants Acetaminophen contains Acetaminophen. It is a suspension taken oral. Consult your doctor for specific uses.

Is CareOne Infants Acetaminophen a controlled substance?

CareOne Infants Acetaminophen is not classified as a controlled substance by the DEA.

What is the generic name for CareOne Infants Acetaminophen?

The generic name for CareOne Infants Acetaminophen is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for CareOne Infants Acetaminophen 160 mg/5mL?

The NDC (National Drug Code) for CareOne Infants Acetaminophen 160 mg/5mL is 41520-363, listed by American Sales Company.

Product NDC

41520-363

Package NDC

41520-363-16

Other Acetaminophen Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)