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  5. Label Information: Childrens Tussnex Multi-symptom Cold

FDA Label for Childrens Tussnex Multi-symptom Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PDP

Childrens Tussnex Multi-symptom Cold Product Label

The following document was submitted to the FDA by the labeler of this product Guardian Drug 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

Phenylephrine HCl 2.5 mg


Purpose



Cough suppressant

Expectorant

Nasal decongestant


Uses



  • 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 intensity of coughing
  • the impulse to cough to help your child get to sleep
  • nasal congestion due to a cold
  • stuffy nose

Warnings



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 prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


Ask A Doctor Before Use If The Child Has



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

When Using This Product



  • do not use more than directed

Stop Use And Ask A Doctor If



  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with 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
  • dose as follows or as directed by a doctor

    •  AgeDose 
     children 6 years to under 12 years 10 mL every 4 hours
     children 4 years to under 6 years 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 15-30oC (59-86oF)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



citric acid anhydrous, D and C red 33, dextrose, edetate disodium, FD and C blue 1, FD and C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum


Pdp



compare to active ingredients in Mucinex children's Multi-symptom cold

Children's Tussnex Multi-symptom cold

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal decongestant

Relieves nasal and chest chest congestion

Thins and loosens mucus

Soothes cough

Alcohol free


* Please review the disclaimer below.