FDA Label for Childrens Multi Symptom Cold Very Berry

View Indications, Usage & Precautions

Childrens Multi Symptom Cold Very Berry Product Label

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



  • 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 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
  • Age Dose 
    children 6 years to under 12 years10 mL every 4 hours
    children 4 years to under 6 years5 mL every 4 hours
    children under 4 yearsdo not use
    • mL=milliliter

Other Information



  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30 °C (59-86 °F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



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


Principal Display Panel



CVS
Health®

Compare to the active ingredients in Children's Mucinex® Multi-Symptom Cold*
NDC 51316-815-03

Children's Multi-Symptom Cold

Dextromethorphan HBr 5 mg
Cough Suppressant

Guaifenesin
Expectorant

Phenylephrine HCl

Nasal Decongestant 

Relieves:

Nasal & chest congestion

Soothes cough

Thins & loosens mucus


Alcohol Free

Ages 4+ Years


Very Berry Flavor

Dosage Cup Included


4FL OZ (118 mL)

 


* Please review the disclaimer below.