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  5. Label Information: Childrens Multi-symptom Cold

FDA Label for Childrens Multi-symptom Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Childrens Multi-symptom Cold Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores, 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.

Active Ingredient(S)



Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenyephrine HCl 2.5 mg


Purpose



Cough Suppressant

Expectorant

Phenylephrine HCl


Use(S)



  • 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 the common 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



  • 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
  • mL = milliliter


    • Age Dose  
    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 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients



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


Principal Display Panel



NDC 49035-715-03

equate

Compare to Children's Mucinex® Multi-Symptom Cold active ingredients*

Children's Multi-Symptom Cold

Dextromethorphan HBr 5 mg

Cough Suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal Decongestant

Ages 4 to 12 years

Relieves Stuffy Nose   
Soothes Cough   

Relieves Chest Congestion   

Thins and loosens Mucus

Alcohol Free

Very Berry Flavored 

4 FL OZ (118 mL)

615 - NDC715

615 - NDC715


* Please review the disclaimer below.