Dye Free Infants Pain and Fever 160 mg/5mL

acetaminophen · SUSPENSION · FAMILY DOLLAR SERVICES INC

1 Recall on RecordCurrently in Shortage

Plain English

Dye Free Infants Pain and Fever is a suspension containing acetaminophen at 160 mg/5mL, taken oral. Manufactured by FAMILY DOLLAR SERVICES INC.

Key Facts

Brand Name: Dye Free Infants Pain and Fever
Generic Name: acetaminophen
NDC Code (Product): 55319-206
Manufacturer: FAMILY DOLLAR SERVICES INC
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 05/08/2023

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

fatigue20,435 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

Frequently Asked Questions

What is Dye Free Infants Pain and Fever used for?

Dye Free Infants Pain and Fever contains acetaminophen. It is a suspension taken oral. Consult your doctor for specific uses.

Is Dye Free Infants Pain and Fever a controlled substance?

Dye Free Infants Pain and Fever is not classified as a controlled substance by the DEA.

What is the generic name for Dye Free Infants Pain and Fever?

The generic name for Dye Free Infants Pain and Fever is acetaminophen. There are 12 other brand versions of acetaminophen.

What is the NDC code for Dye Free Infants Pain and Fever 160 mg/5mL?

The NDC (National Drug Code) for Dye Free Infants Pain and Fever 160 mg/5mL is 55319-206, listed by FAMILY DOLLAR SERVICES INC.

Product NDC

55319-206

Package NDC

55319-206-02

Other Acetaminophen Brands

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

Data from openFDA · Public domain (CC0 1.0)