Drugplain

infants pain fever 160 mg/5mL

Acetaminophen · SUSPENSION · H E B

5 Recalls on RecordCurrently in Shortage
Plain English

Infants Pain Fever is an over-the-counter liquid suspension containing acetaminophen used to reduce fever and relieve pain in infants. Each 5 milliliter dose contains 160 milligrams of acetaminophen.

Key Facts

Brand Name
infants pain fever
Generic Name
Acetaminophen
NDC Code (Product)
59640-766
Manufacturer
H E B
Strength
160 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
07/22/2024

Recall History

5 Recalls on Record
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated
Class II11/13/2023

KINDER FARMS LLC

Failed Impurities/Degradation Specifications

OngoingVoluntary: Firm initiated
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use22,386 reports
fatigue20,435 reports
drug ineffective18,155 reports
pain18,103 reports
nausea17,623 reports
headache16,714 reports
toxicity to various agents15,539 reports
dyspnoea14,575 reports
arthralgia14,309 reports
pyrexia14,271 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 infants pain fever used for?

Infants Pain Fever is an over-the-counter liquid suspension containing acetaminophen used to reduce fever and relieve pain in infants. Each 5 milliliter dose contains 160 milligrams of acetaminophen.

Is infants pain fever a controlled substance?

infants pain fever is not classified as a controlled substance by the DEA.

What is the generic name for infants pain fever?

The generic name for infants pain fever is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for infants pain fever 160 mg/5mL?

The NDC (National Drug Code) for infants pain fever 160 mg/5mL is 59640-766, listed by H E B.