Drugplain

Multi-Symptom Cold 325 mg/1

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl · TABLET, FILM COATED · Valu Merchandisers Company

8 Recalls on RecordCurrently in Shortage
Plain English

Multi-Symptom Cold is a tablet, film coated containing acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Valu Merchandisers Company.

Key Facts

Brand Name
Multi-Symptom Cold
Generic Name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
NDC Code (Product)
63941-473
Manufacturer
Valu Merchandisers Company
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/21/2005

Recall History

8 Recalls on Record
Class III04/25/2014

Prestige Brands Holdings

Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

TerminatedVoluntary: Firm initiated
Class III05/15/2013

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class III02/04/2014

Aaron Industries Inc

Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.

TerminatedVoluntary: Firm initiated
Class III01/18/2013

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

TerminatedVoluntary: Firm initiated
Class III04/25/2014

Prestige Brands Holdings

Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

TerminatedVoluntary: Firm initiated
Class III01/18/2013

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

TerminatedVoluntary: Firm initiated
Class III05/15/2013

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

cerebrovascular accident128 reports
product use in unapproved indication79 reports
drug effective for unapproved indication72 reports
drug ineffective54 reports
cough34 reports
haemorrhagic stroke31 reports
drug hypersensitivity26 reports
somnolence25 reports
convulsion24 reports
dyspnoea24 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation

Dosage & Administration

Directions do not take more then 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use

Warnings

Warnings Do not use 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 heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product, do not use more than directed. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case

Frequently Asked Questions

What is Multi-Symptom Cold used for?

Multi-Symptom Cold contains Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Multi-Symptom Cold a controlled substance?

Multi-Symptom Cold is not classified as a controlled substance by the DEA.

What is the generic name for Multi-Symptom Cold?

The generic name for Multi-Symptom Cold is Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl. There are 6 other brand versions of Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl.

What is the NDC code for Multi-Symptom Cold 325 mg/1?

The NDC (National Drug Code) for Multi-Symptom Cold 325 mg/1 is 63941-473, listed by Valu Merchandisers Company.

Product NDC

63941-473

Package NDC

63941-473-08

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

Data from openFDA · Public domain (CC0 1.0)