Mucinex® Children's Multi-symptom Cold

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2018-03-30 Until 2023-03-15

Medication Information

Description

Drug Facts

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product do not use more than directed

Section 50570-1

Do not usein 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.

Section 55105-1

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

do not give 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 to under 12 years of age	10 mL every 4 hours
children 4 to under 6 years of age	5 mL every 4 hours
children under 4 years of age	do not use

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Information

each 5 mL contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not refrigerate

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
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 condition.

Ask A Doctor Before Use If the Child Has

heart disease
high blood pressure
thyroid disease
diabetes
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

Principal Display Panel 118 Ml Bottle Carton

Pediatrician Recommended ^†

NDC 63824-949-01

Mucinex®

Children's

MULTI-SYMPTOM

COLD

Dextromethorphan HBr 5 mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

Relieves Stuffy Nose
Controls Cough
Relieves Chest Congestion
Breaks up Mucus

Ages

4 ⁺

yrs

Very Berry

Flavor Liquid

4 FL OZ (118 mL)

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50570-1 (50570-1)

Do not usein 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.

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 mg	Nasal decongestant

Directions

do not give 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 to under 12 years of age	10 mL every 4 hours
children 4 to under 6 years of age	5 mL every 4 hours
children under 4 years of age	do not use

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Other Information (Other information)

each 5 mL contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not refrigerate

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
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 condition.

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
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

Pediatrician Recommended ^†

NDC 63824-949-01

Mucinex®

Children's

MULTI-SYMPTOM

COLD

Dextromethorphan HBr 5 mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

Relieves Stuffy Nose
Controls Cough
Relieves Chest Congestion
Breaks up Mucus

Ages

4 ⁺

yrs

Very Berry

Flavor Liquid

4 FL OZ (118 mL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not use more than directed", "50570-1": "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.", "55105-1": "Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 mg Nasal decongestant", "Directions": "do not give 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 to under 12 years of age 10 mL every 4 hours children 4 to under 6 years of age 5 mL every 4 hours children under 4 years of age do not use", "Questions?": "1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.", "Other information": "each 5 mL contains: sodium 3 mg store between 20-25°C (68-77°F) do not refrigerate", "Inactive ingredients": "anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur 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 condition.", "Ask a doctor before use if the child has": "heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton": "Pediatrician Recommended † NDC 63824-949-01 Mucinex® Children's MULTI-SYMPTOM COLD Dextromethorphan HBr 5 mg - Cough Suppressant Guaifenesin 100 mg - Expectorant Phenylephrine HCl 2.5 mg - Nasal Decongestant Relieves Stuffy Nose Controls Cough Relieves Chest Congestion Breaks up Mucus Ages 4 + yrs Very Berry Flavor Liquid 4 FL OZ (118 mL)"}

Mucinex® Children's Multi-symptom Cold

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information