Children's

Children's
SPL v2
SPL
SPL Set ID ce565113-e9e3-46de-84f7-3a432acb0e4b
Route
ORAL
Published
Effective Date 2012-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (5 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid D&c Red No. 33 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-01
Description

Drug Facts

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
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 50566-9

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

Section 50569-3

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
Section 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.

Section 55105-1
Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
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
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL – 10 mL every 4 hours
children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours
children under 4 years do not use
Questions?

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

You may also report side effects to this phone number.

Other Information
  • tamper evident: do not use if printed neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, xanthan gum

Principal Display Panel 118 Ml Bottle Carton

NDC 63824-281-64

Children's

Mucinex®

Cough

Guaifenesin 100 mg

Dextromethorphan HBr 5 mg

Expectorant

Cough Suppressant

✓Cough

✓Chest Congestion

✓Breaks up Mucus

✓Alcohol-free

Cherry

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
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 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (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.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
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
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL – 10 mL every 4 hours
children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours
children under 4 years 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)
  • tamper evident: do not use if printed neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, xanthan gum

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

NDC 63824-281-64

Children's

Mucinex®

Cough

Guaifenesin 100 mg

Dextromethorphan HBr 5 mg

Expectorant

Cough Suppressant

✓Cough

✓Chest Congestion

✓Breaks up Mucus

✓Alcohol-free

Cherry

Flavor Liquid

4 FL OZ

(118 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:33.113229 · Updated: 2026-03-14T22:53:19.872567