Mucinex® Children's

Mucinex® Children's
SPL v2
SPL
SPL Set ID 66543190-1d3d-4259-ae73-d366ecbf9e52
Route
ORAL
Published
Effective Date 2022-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Aspartame Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Carboxymethylcellulose Sodium, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Sodium Bicarbonate Sorbitol Stearic Acid Talc Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-27

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 as may occur with a cold.
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 ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50567-7

When using this product do not use more than directed

Section 50570-1

Do not useif you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients (in each packet) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Directions
  • empty entire contents of packet onto tongue and swallow
  • for best taste, do not chew granules
  • do not give more than 6 doses in any 24-hour period
  • dose as follows or as directed by a doctor
Age Dose
adults and Children 12 years of age and over 2 to 4 packets every 4 hours
children 6 years to under 12 years of age 1 to 2 packets every 4 hours
children 4 years to under 6 years of age 1 packet every 4 hours
children under 4 years of age do not use
Questions?

1-866-682-4639

You may also report side effects to this phone number.

Other Information
  • each packet contains: magnesium 6 mgand sodium 3 mg
  • phenylketonurics: contains phenylalanine 2 mg per packet
  • store at 20-25°C (68-77°F)
Inactive Ingredients

aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate

Ask A Doctor Before Use If You Have
  • persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
Principal Display Panel 12 Packet Carton

Pediatrician Recommended*

NDC 63824-943-12

Mucinex®

children's

COUGH AND

CHEST CONGESTION

Dextromethorphan HBr 5 mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

  • Controls Cough
  • Relieves Chest Congestion
  • Thins and Loosens Mucus

Ages

4 +years

Orange Crème

Flavor

12 GRANULE PACKETS


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 as may occur with a cold.
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 ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50570-1 (50570-1)

Do not useif you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each packet) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Directions
  • empty entire contents of packet onto tongue and swallow
  • for best taste, do not chew granules
  • do not give more than 6 doses in any 24-hour period
  • dose as follows or as directed by a doctor
Age Dose
adults and Children 12 years of age and over 2 to 4 packets every 4 hours
children 6 years to under 12 years of age 1 to 2 packets every 4 hours
children 4 years to under 6 years of age 1 packet every 4 hours
children under 4 years of age do not use
Questions?

1-866-682-4639

You may also report side effects to this phone number.

Other Information (Other information)
  • each packet contains: magnesium 6 mgand sodium 3 mg
  • phenylketonurics: contains phenylalanine 2 mg per packet
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
Principal Display Panel 12 Packet Carton (PRINCIPAL DISPLAY PANEL - 12 Packet Carton)

Pediatrician Recommended*

NDC 63824-943-12

Mucinex®

children's

COUGH AND

CHEST CONGESTION

Dextromethorphan HBr 5 mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

  • Controls Cough
  • Relieves Chest Congestion
  • Thins and Loosens Mucus

Ages

4 +years

Orange Crème

Flavor

12 GRANULE PACKETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)