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  5. Label Information: Mucinex Childrens Cough

FDA Label for Mucinex Childrens Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Mucinex Childrens Cough Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) 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

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England


Otc - Purpose



Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

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

Otc - Do Not Use



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

Otc - When Using



When using this product do not use more than directed


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 condition.


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 give more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
    • AgeDose
    children 6 years to under 12 years of age5 mL – 10 mL every 4 hours
    children 4 years to under 6 years of age2.5 mL – 5 mL every 4 hours
    children under 4 years of agedo not use

Other Information



  • each 5 mL contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive Ingredients



anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, 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



Pediatrician Recommended†

NDC 63824-946-03

Mucinex®
Children's

COUGH

Dextromethorphan HBr 5 mg – Cough Suppressant
Guaifenesin 100 mg – Expectorant

* Please review the disclaimer below.