Childrens Multi-symptom Cold Liquid
FDA Label NDC 49035-715

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Childrens Multi-symptom Cold (NDC 49035-715). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.