INFANTS Pain and Fever 160 mg/5mL

Acetaminophen · SUSPENSION · Aurohealth LLC

1 Recall on RecordCurrently in Shortage

Plain English

Infants Pain and Fever is an over-the-counter oral suspension containing acetaminophen that helps reduce fever and relieve pain in infants. Each 5 mL dose contains 160 mg of acetaminophen.

Key Facts

Brand Name: INFANTS Pain and Fever
Generic Name: Acetaminophen
NDC Code (Product): 58602-168
Manufacturer: Aurohealth LLC
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 03/20/2026

Recall History

1 Recall 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

Side Effects Reported to FDA

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

off label use22,386 reports

fatigue20,436 reports

drug ineffective18,152 reports

pain18,105 reports

nausea17,622 reports

headache16,715 reports

toxicity to various agents15,539 reports

dyspnoea14,574 reports

arthralgia14,307 reports

pyrexia14,271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Usage Purpose: Pain reliever/fever reducer Uses temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache

Dosage & Administration

Dosing & Directions 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 cap and seal, then insert the adapter plug by pushing down firmly until a tight seal is formed ▪ top of plug should be flush with bottle neck and not removeable ▪ push air out of syringe and insert syringe tip into adapter plug opening ▪ flip bottle upside down ▪ pull plunger of syringe up to 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 Weight (lb) Age (yr) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 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 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 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 before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning)

Frequently Asked Questions

What is INFANTS Pain and Fever used for?

Infants Pain and Fever is an over-the-counter oral suspension containing acetaminophen that helps reduce fever and relieve pain in infants. Each 5 mL dose contains 160 mg of acetaminophen.

Is INFANTS Pain and Fever a controlled substance?

INFANTS Pain and Fever is not classified as a controlled substance by the DEA.

What is the generic name for INFANTS Pain and Fever?

The generic name for INFANTS Pain and Fever is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for INFANTS Pain and Fever 160 mg/5mL?

The NDC (National Drug Code) for INFANTS Pain and Fever 160 mg/5mL is 58602-168, listed by Aurohealth LLC.

Product NDC

58602-168

Package NDC

58602-168-11

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)