Maximum Strength Mucus Relief Liquid
FDA Label NDC 42507-630

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Maximum Strength Mucus Relief (NDC 42507-630). 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 active ingredients (in each 20 ml), purpose, use(s), warnings, do not use, ask a doctor before use if, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg


Purpose

Cough Suppressant

Expectorant


Use(S)

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

Warnings

.

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

  • 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 Doctor If

  • cough lasts more than 7 days, 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.

Keep Out Of Reach Of Children

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

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
  • Adults & children 12 years & older: 20 mL every 4 hours
  • Children under 12 years of age: Do not use






Other Information

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

Inactive Ingredients

citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40,  flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

Package Label.Principal Display Panel

HyVee®

 

*COMPARE TO the Active Ingredients in Maximum Strength MUCINEX® FAST MAX DM MAX


Maximum Strength
Mucus Relief 

Cough Suppressant / Expectorant


 

Controls Cough 

Relieves Chest Congestion    

Thins and loosens Mucus


6 FL OZ (177 mL)

CHERRY FLAVOR

 

628-6-hv-front.jpg (628 6 Hv Front)

628-6-hv-front.jpg (628 6 Hv Front)

628-6-hv-back.jpg (628 6 Hv Back)

628-6-hv-back.jpg (628 6 Hv Back)


* Please review the disclaimer below.