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  5. Label Information: Childrens Mucinex Cough

FDA Label for Childrens Mucinex Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    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 - 188 ML BOTTLE CARTON

Childrens Mucinex Cough Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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.

Other



Drug Facts

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



Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146


Otc - Purpose



Active ingredients
(in each 5 mL)		Purpose
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.


Otc - Ask Doctor



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



  • each 5 mL contains: sodium 3 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



citric acid anhydrous, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum


Questions?



1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.


Principal Display Panel - 188 Ml Bottle Carton



Children's
Mucinex®

Cough

Expectorant
Cough Suppressant

Guaifenesin 100 mg
Dextromethorphan HBr 5 mg

Cough
Chest Congestion
Breaks up Mucus

Cherry
Flavor Liquid

4 FL OZ
(118 mL)

NDC 54868-6125-0


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