Drugplain

Tylenol Cold Plus Flu Severe Severe 325 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE · TABLET, FILM COATED · Jones Healthcare Group - Packaging Services, Inc

No Recall HistoryCurrently in Shortage
Plain English

Tylenol Cold Plus Flu Severe Severe is a tablet, film coated containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Jones Healthcare Group - Packaging Services, Inc.

Key Facts

Brand Name
Tylenol Cold Plus Flu Severe Severe
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
67414-402
Manufacturer
Jones Healthcare Group - Packaging Services, Inc
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
01/25/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

drug administration error4 reports
inappropriate schedule of product administration3 reports
drug screen positive2 reports
hyperhidrosis2 reports
incorrect dose administered2 reports
product administration error2 reports
anxiety1 reports
ascites1 reports
cervical vertebral fracture1 reports
diarrhoea1 reports

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: If a skin reaction occurs, stop use and seek medical help right away. skin reddening blisters rash 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 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 th

Frequently Asked Questions

What is Tylenol Cold Plus Flu Severe Severe used for?

Tylenol Cold Plus Flu Severe 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 Plus Flu Severe Severe a controlled substance?

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

What is the generic name for Tylenol Cold Plus Flu Severe Severe?

The generic name for Tylenol Cold Plus Flu Severe Severe is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. There are 11 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE.

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

The NDC (National Drug Code) for Tylenol Cold Plus Flu Severe Severe 325 mg/1 is 67414-402, listed by Jones Healthcare Group - Packaging Services, Inc.