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  5. Label Information: Childrens Mucinex Chest Congestion

FDA Label for Childrens Mucinex Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Childrens Mucinex Chest Congestion Product Label

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

Other



Drug Facts


Active Ingredient (In Each 5 Ml)



Guaifenesin, USP 100 mg


Purpose



Expectorant


Uses



helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


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

Otc - Stop Use



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 illness.


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.


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
    • AgeDose
    children 6 years to under 12 years5 mL – 10 mL
    every 4 hours
    children 4 years to under 6 years2.5 mL – 5 mL
    every 4 hours
    children under 4 yearsdo not use

Other Information



  • tamper evident: do not use if printed neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum


Questions?



1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.


Principal Display Panel - 118 Ml Bottle Carton



NDC 63824-280-64

Children's
Mucinex®

Chest
Congestion

Guaifenesin Oral Solution, USP
Expectorant

* Please review the disclaimer below.