Drugplain

Tylenol Cold Flu Severe 325 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE · TABLET, FILM COATED · JC World Bell Wholesale Co., Inc.

No Recall HistoryCurrently in Shortage
Plain English

Tylenol Cold Flu Severe is a tablet, film coated containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by JC World Bell Wholesale Co., Inc..

Key Facts

Brand Name
Tylenol Cold Flu Severe
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
50269-550
Manufacturer
JC World Bell Wholesale Co., Inc.
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
09/01/2011

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reactions occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompained 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 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

Frequently Asked Questions

What is Tylenol Cold Flu Severe used for?

Tylenol Cold Flu Severe contains ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Tylenol Cold Flu Severe a controlled substance?

Tylenol Cold Flu Severe is not classified as a controlled substance by the DEA.

What is the generic name for Tylenol Cold Flu Severe?

The generic name for Tylenol Cold Flu Severe is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. There are 12 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE.

What is the NDC code for Tylenol Cold Flu Severe 325 mg/1?

The NDC (National Drug Code) for Tylenol Cold Flu Severe 325 mg/1 is 50269-550, listed by JC World Bell Wholesale Co., Inc..