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  5. Label Information: Childrens Mucus And Cough Relief

FDA Label for Childrens Mucus And Cough Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSE
    3. USE(S)
    4. WARNING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND A ASK DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Childrens Mucus And Cough Relief Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar Services, Inc.. 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 (In Each 5 Ml)



Dextromethorphan HBr 5 mg
Guaifenesin 100 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 impulse to cough to help your child get to sleep 
      • the intensity of coughing

Warning



.


Do Not Use



in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.



Ask A Doctor Before Use If You Have



  • persistent or chronic cough such as occurs with asthma 
  • cough that occurs with too much phlegm (mucus)


Stop Use And A Ask Doctor If



  •  cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. 


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
  • mL=milliliter


    • Age  Dose
     children 6 years to under 12 years 5 mL-10 mL
    every 4 hours
     children 4 years to under 6 years 2.5 mL - 5 mL
    every 4 hours
     children under 4 years do not use





Other Information



  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



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


Principal Display Panel



FAMILY WellnessTM
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX COUGH*


children's 

MUCUS RELIEF

AGES 4-12 YEARS


COUGH SUPPRESSANT & EXPECTORANT

 
Dextromethorphan HBr 5mg

Guaifenesin 100 mg


  • Controls cough
  • Relieves chest congestion
  • Thins and Loosens Mucus
  • Alcohol Free 

    •      CHERRY FLAVORED LIQUID

         4 FL OZ (118 mL)

    552-carton-fw.jpg - 552 carton fw

    552-carton-fw.jpg - 552 carton fw

     


      



* Please review the disclaimer below.