Severe Congestion And Cough Max Solution
FDA Label NDC 53942-517

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Market Basket for the product Severe Congestion And Cough Max (NDC 53942-517). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifensin 400 mg
Phenylephrine HCL 10 mg

Purpose

Dextromethorphan HBr ........Cough suppressant
Guaifensin ..........................Expectorant
Phenylephrine .....................Nasal decongestan

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:

      •       • cough due to minor throat and bronchial irritation

            • nasal congestion

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.
• For children under 12 years of age

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes
• trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis or emphysema •cough that occurs with too much phlegm (mucus)

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 a
fever • cough comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only as recommended 
  • use dosage cup
  • mL = milliliter
  • do not take more than 6 doses in any 24-hour period
    •             Age                                                                                              Dose                         
     Adults & children 12 years and older 20 ml every 4 hours
     Children under 12 years of age       Do not use

Other Safety Information

Other information

  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30° C (59-86° F)
  • do not refrigerate

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD and C Blue  #1, FD and C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Maximum Strength Max Severe Congestion & Cough - Principal Display Panel

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"MORE FOR YOUR DOLLAR"

MARKET BASKET

Compare to Mucinex· FAST-MAX™ Severe Congestion
& Cough active ingredients​*

Maximum Strength
Max Severe Congestion & Cough

Congestion & Cough

Dextromethorphan HBr/
Cough Suppressant
Guaifenesin /Expectorant
Phenylephrine HCI / Nasal Decongestant

Relief of:
• Cough
• Thins & Loosens Mucus
• Nasal & Chest Congestion

Adults- For Ages 12 and over
6 Fl OZ ( 177 mL)

*This product is not manufactured or

distributed by Reckitt Benckiser Inc.,

distributor of Mucinex® FAST-MAX™ 

Severe Congestion & Cough.


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DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 East Street
Tewksbury, MA 01876

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