Drugplain

Cold and Flu Severe, Day, Night

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr. Guaifenesin, Phenylephrine HCl · KIT · L.N.K. International, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Cold and Flu Severe, Day, Night is a kit containing acetaminophen, chlorpheniramine maleate, dextromethorphan hbr. guaifenesin, phenylephrine hcl. Manufactured by L.N.K. International, Inc..

Key Facts

Brand Name
Cold and Flu Severe, Day, Night
Generic Name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr. Guaifenesin, Phenylephrine HCl
NDC Code (Product)
50844-547
Manufacturer
L.N.K. International, Inc.
Dosage Form
KIT
Marketing Status
Application #
M012
Marketing Start
07/15/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

device difficult to use1 reports
disease progression1 reports
drug ineffective1 reports
eye pain1 reports
nasopharyngitis1 reports
neutropenia1 reports
ocular discomfort1 reports
platelet count decreased1 reports
product dose omission issue1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses •temporarily relieves these symptoms due to a cold or flu:  • minor aches and pains  • headache • sore throat  • cough  • temporarily reduces fever

Dosage & Administration

Directions Directions ● do not take more than the recommended dose ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 10 tablets in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: ● skin reddening ● blisters ● rash ● hives ● facial swelling ● asthma (wheezing) ● shock If a skin or general allergic 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.

Frequently Asked Questions

What is Cold and Flu Severe, Day, Night used for?

Cold and Flu Severe, Day, Night contains Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr. Guaifenesin, Phenylephrine HCl. It is a kit taken as directed. Consult your doctor for specific uses.

Is Cold and Flu Severe, Day, Night a controlled substance?

Cold and Flu Severe, Day, Night is not classified as a controlled substance by the DEA.

What is the generic name for Cold and Flu Severe, Day, Night?

The generic name for Cold and Flu Severe, Day, Night is Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr. Guaifenesin, Phenylephrine HCl. There are no other listed brand versions of Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr. Guaifenesin, Phenylephrine HCl.

What is the NDC code for Cold and Flu Severe, Day, Night ?

The NDC (National Drug Code) for Cold and Flu Severe, Day, Night is 50844-547, listed by L.N.K. International, Inc..

Product NDC

50844-547

Package NDC

50844-547-08

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

Data from openFDA · Public domain (CC0 1.0)