FDA Label for Severe Congestion And Cough Max Maxium Strength

View Indications, Usage & Precautions

Severe Congestion And Cough Max Maxium Strength Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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.

Active Ingredients



Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg


Purpose



Cough suppressant
Expectorant
Nasal Decongestant


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.


Uses



  • helps to 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
  • for children under 12 years of age

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.


Directions



Other Information



    each 20 mL teaspoon contains:

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

Inactive Ingredients



citric acid anhydrous, 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


Product Label



NDC 68016-221-00
*COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™  SEVERE CONGESTION AND COUGH LF-004

Premier Value®

Maximum Strength
Severe Congestion and Cough MAX

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL
COUGH SUPPRESSANT / EXPECTORANT/ NASAL DECONGESTANT


  • Controls Cough
  • Thins and Loosens Mucus
  • Relieves Nasal and Chest Congestion

  • Adults

    For Ages 12 and Over

     6 FL OZ (177mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Peel Corner to read Complete Drug Facts and Information     

    Lot:    Exp:

    *This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® FAST-MAX™  DM MAX

    If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431


    LF-004




* Please review the disclaimer below.