Drugplain

Tussnex FM Cold and Sinus 650 mg/20mL

Acteaminophen, Guaifenesin, Phenylephrine HCl · LIQUID · Guardian Drug Company

No Recall History
Plain English

Tussnex FM Cold and Sinus is a liquid containing acteaminophen, guaifenesin, phenylephrine hcl at 650 mg/20mL, taken oral. Manufactured by Guardian Drug Company.

Key Facts

Brand Name
Tussnex FM Cold and Sinus
Generic Name
Acteaminophen, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
53041-616
Manufacturer
Guardian Drug Company
Strength
650 mg/20mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
12/01/2012

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Dosage & Administration

Directions do not take more than directed (see overdose warning) do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours. Children under 12 years of age: Do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking,

Frequently Asked Questions

What is Tussnex FM Cold and Sinus used for?

Tussnex FM Cold and Sinus contains Acteaminophen, Guaifenesin, Phenylephrine HCl. It is a liquid taken oral. Consult your doctor for specific uses.

Is Tussnex FM Cold and Sinus a controlled substance?

Tussnex FM Cold and Sinus is not classified as a controlled substance by the DEA.

What is the generic name for Tussnex FM Cold and Sinus?

The generic name for Tussnex FM Cold and Sinus is Acteaminophen, Guaifenesin, Phenylephrine HCl. There are no other listed brand versions of Acteaminophen, Guaifenesin, Phenylephrine HCl.

What is the NDC code for Tussnex FM Cold and Sinus 650 mg/20mL?

The NDC (National Drug Code) for Tussnex FM Cold and Sinus 650 mg/20mL is 53041-616, listed by Guardian Drug Company.

Product NDC

53041-616

Package NDC

53041-616-58

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

Data from openFDA · Public domain (CC0 1.0)