Maximum Strength Mucus Relief Severe Congestion And Cough Liquid
FDA Label NDC 41163-738

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Supervalu Inc., for the product Maximum Strength Mucus Relief Severe Congestion And Cough (NDC 41163-738). 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 other, otc - purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients
(in each 20 mL)		Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold

Do Not Use

  • for children under 12 years of age
  • 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough 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 occur with fever
  • cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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 1-800-222-1222

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • Adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours.
  • Children under 12 years of age: Do not use.

Other Information

  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-932-7948

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EQUALINE®

NDC 41163-738-06

Compare toMucinex® Fast- Max™ Maximum strength Severe Congestion & Cough active ingredients*

maximum strength‡

severe congestion and cough


dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)

  • controls cough
  • relieves nasal and chest congestion
  • thins and loosens mucus

    • 6 FL OZ (180 mL)


    for ages 12+

    Tamper evident: do not use if printed seal under cap is broken or missing.

    ‡Maximum Strength per 4 hour dose.

    DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

    877-932-7948, supervaluprivatebrands.com

    ‡Maximum Strength per 4 hour dose.

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®

    Fast -Max® Maximum Strength Severe Congestion & Cough.

    Equaline Maximum Strength Mucus Relief Severe Congestion And Cough 6 Fl Oz (180 mL) (Mucinex 01)

    Equaline Maximum Strength Mucus Relief Severe Congestion And Cough 6 Fl Oz (180 mL) (Mucinex 01)

* Please review the disclaimer below.