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  5. Label Information: Cough Childrens

FDA Label for Cough Childrens

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Cough Childrens Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen 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.

Active Ingredients (In Each 5 Ml)



Dextromethorphan HBr 5 mg

Guaifenesin 100 mg


Purpose



Cough suppressant

Expectorant


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 your child get to sleep

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 The Child Has



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

Stop Use And Ask A 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.


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
  • •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



  • •do not use if printed neckband is broken or missing
  • •store at 20-25°C (68-77°F)
  • •do not refrigerate
  • •dosing cup provided

Inactive Ingredients



acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to Children’s Mucinex® Cough active ingredients

children’s Cough

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

ALCOHOL FREE

Breaks up the mucus that causes congestion while controlling coughs

AGES 4 – 12 YEARS

CHERRY FLAVOR

4 FL OZ (118 mL)


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