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  5. Label Information: Childrens Cough

FDA Label for Childrens Cough

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. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL

Childrens Cough Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores, 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, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum


Questions?



1-888-287-1915


Principal Display Panel



NDC 49035-773-03

equate
Compare to Children's Mucinex Cough active ingredients*
children's 
COUGH LIQUID
Dextromethorphan HBr 5mg
Cough Suppressant

Guaifenesin 100 mg

Expectorant

AGES 4 TO 12 YEARS


  • Controls cough
  • Thins and Loosens Mucus
  • Relieves chest congestion
  • Non-Drowsy
  • Alcohol Free
  • Cherry Flavored

    • 4 FL OZ (118 mL)



    773 - 552

    773 - 552


* Please review the disclaimer below.