Drugplain

Cough and Cold plus 325 mg/1

Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr · CAPSULE, LIQUID FILLED · Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd

No Recall HistoryCurrently in Shortage
Plain English

Cough and Cold Plus is an over-the-counter oral medication that combines a pain reliever (acetaminophen), a decongestant (phenylephrine), an antihistamine (chlorpheniramine), and a cough suppressant (dextromethorphan) to help relieve multiple cold and cough symptoms. It is available as an oral capsule or liquid-filled form.

Key Facts

Brand Name
Cough and Cold plus
Generic Name
Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr
NDC Code (Product)
53345-045
Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
03/24/2017

Recall History

No Recall History

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 nasal and sinus congestion cough runny nose sneezing sore throat temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels 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 softgels 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 reactions. Symptoms may include: skin reddening blisters rash If a skin 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. Do not use to sedate children. 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 this product. if you have

Frequently Asked Questions

What is Cough and Cold plus used for?

Cough and Cold Plus is an over-the-counter oral medication that combines a pain reliever (acetaminophen), a decongestant (phenylephrine), an antihistamine (chlorpheniramine), and a cough suppressant (dextromethorphan) to help relieve multiple cold and cough symptoms. It is available as an oral capsule or liquid-filled form.

Is Cough and Cold plus a controlled substance?

Cough and Cold plus is not classified as a controlled substance by the DEA.

What is the generic name for Cough and Cold plus?

The generic name for Cough and Cold plus is Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr. There are no other listed brand versions of Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr.

What is the NDC code for Cough and Cold plus 325 mg/1?

The NDC (National Drug Code) for Cough and Cold plus 325 mg/1 is 53345-045, listed by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Product NDC

53345-045

Package NDC

53345-045-01

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

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