FDA Label for Kroger Maximum Strength Severe Congestion And Cough

View Indications, Usage & Precautions

Kroger Maximum Strength Severe Congestion And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



  • ▪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
  • ▪low sodium
  • ▪store at room temperature
  • ▪do not refrigerate

Inactive Ingredients



anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum


Questions Or Comments?



1-866-467-2748


Principal Display Panel



NDC 30142-738-06

Compare to Mucinex® Fast- Max® Maximum Strength Severe Congestion & Cough Active Ingredients*

Maximum Strength

Severe Congestion & Cough
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

  • •Control Cough
  • •Relieves Nasal and Chest Congestion
  • •Thins & loosens mucus
  • For Ages 12+

    6 FL OZ (180 mL)

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

    *This product is not manufactured or distributed by RB Health (US) LLC, the distributor of Mucinex® and Fast-Max® Maximum Strength Severe Congestion & Cough.

    Distributed by:


* Please review the disclaimer below.