FDA Label for Leader Childrens Multi Symptom Cold

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 (1-800-222-1222) 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 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

Questions Or Comments?

call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est

Principal Display Panel

LEADER

NDC 70000-0629-1

Children's Multi-Symptom Cold

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Cough Suppressant

Expectorant

Nasal Decongestant

Very Berry Flavor

Ages 4+ Years

Relieves:

Stuffy Nose

Chest Congestion

Controls Cough

Breaks Up Mucus

COMPARE TO

CHILDREN'S MUCINEX^®

MULTI-SYMPTOM COLD

active ingredients*

4FL OZ (118 mL)

LDR_615_Carton - leader615carton