Leader Childrens Multi  Symptoms Cold  615

Leader Childrens Multi  Symptoms Cold  615
SPL v2
SPL
SPL Set ID 2a849ae9-338f-4642-e063-6394a90a1ca4
Route
ORAL
Published
Effective Date 2025-01-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Dextrose Edetate Disodium Glycerin Methylparaben Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Sorbate Propyl Gallate Propylene Glycol Propylparaben Water Saccharin Sodium Anhydrous Sodium Hydroxide Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-16

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

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

.

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
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.

Other Information
  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30 ºC (59-86 ºF)
  • 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)

 

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.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

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)

Structured Label Content

Uses (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
Purpose (PURPOSE)

Cough suppressant

Expectorant

Nasal decongestant

Warnings (WARNINGS)

.

Directions (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
Do Not Use (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.

Other Information (OTHER INFORMATION)
  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30 ºC (59-86 ºF)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (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 (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)

 

When Using This Product (WHEN USING THIS PRODUCT)
  • do not use more than directed
Stop Use and Ask Doctor If (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. (KEEP OUT OF REACH OF CHILDREN.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each 5 Ml) (ACTIVE INGREDIENTS (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (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)

Advanced Ingredient Data


Raw Label Data

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