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  5. Label Information: Childrens Multi-symptom Cold Daytime

FDA Label for Childrens Multi-symptom Cold Daytime

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 THE CHILD HAS
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT SECTION
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Childrens Multi-symptom Cold Daytime 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

Nasal decongestant


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 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 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

    • 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
    • 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 Ingredient Section



 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, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.


Questions Or Comments?



Call 1-888-287-1915


Principal Display Panel



NDC79903-270-03

equateTM

Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*

Daytime

Ages 4-12 years

 Children's

Multi-Symptom Cold

Dextromethorphan HBr 5 mg -

Cough Suppressant
Guaifenesin 100 mg - Expectorant

Phenylephrine HCl 2.5 mg - 

Nasal Decongestant

* Please review the disclaimer below.