DailyMed - MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

NDC Code(s): 63824-946-03, 63824-946-34
Packager: RB Health (US) LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated June 2, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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ACTIVE INGREDIENT
Active ingredients (in each 5 mL)Purposes - Dextromethorphan HBr 5 mgCough suppressant - Guaifenesin 100 mgExpectorant

Active ingredients (in each 5 mL) Purposes

Dextromethorphan HBr 5 mg Cough suppressant

Guaifenesin 100 mg Expectorant

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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 ...
- 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
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Warnings
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 ...
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.
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
When using this product do not use more than directed

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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

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Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

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 ...

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

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 1, xanthan gum

1

may contain this ingredient

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Questions?
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

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

You may also report side effects to this phone number.
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SPL UNCLASSIFIED SECTION
Dist. by: RB Health (US) Parsippany, NJ 07054-0224 - Made in England

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England
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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Pediatrician Recommended - † NDC 63824-946-03 - Mucinex® Children's - COUGH - Dextromethorphan HBr 5 mg – Cough Suppressant - Guaifenesin 100 mg – Expectorant - Controls Cough - Relieves ...
Pediatrician Recommended †

NDC 63824-946-03

Mucinex®
Children's

COUGH

Dextromethorphan HBr 5 mg – Cough Suppressant
Guaifenesin 100 mg – Expectorant
- Controls Cough
- Relieves Chest Congestion
- Breaks up Mucus
Ages
4 +yrs

Cherry
Flavor Liquid

4 FL OZ (118 mL)

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Age	Dose
children 6 years to under 12 years of age	5 mL – 10 mL every 4 hours
children 4 years to under 6 years of age	2.5 mL – 5 mL every 4 hours
children under 4 years of age	do not use

INGREDIENTS AND APPEARANCE

Product Information

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Published Date (What is this?)	Version	Files
Jun 4, 2025	5 (current)	download
Dec 23, 2024	4	download
Apr 28, 2021	3	download
Dec 7, 2018	2	download
Jun 6, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN
2	1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD
3	1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY
4	1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY

Label: MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

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	NDC
1	63824-946-03
2	63824-946-34

Label: MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

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Drug Label Information

Ask a doctor before use if the child has

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Safety

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MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

Number of versions: 5

MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

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MUCINEX CHILDRENS COUGH- dextromethorphan hydrobromide and guaifenesin solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.