Mucinex® Children's Freefrom Multi-symptom Cold & Stuffy Nose

Mucinex® Children's Freefrom Multi-symptom Cold & Stuffy Nose
SPL v3
SPL
SPL Set ID c07dad99-87b0-419b-9230-7c22a77ecf9e
Route
ORAL
Published
Effective Date 2021-03-16
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
Ammonium Glycyrrhizate Anhydrous Citric Acid Edetate Disodium Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01

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
    • 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 50566-9

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.
Section 50567-7

When using this product do not use more than directed

Section 50569-3

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)
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 at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Principal Display Panel 118 Ml Bottle Carton

Pediatrician Recommended

DAYTIME

NDC 63824-956-64

Mucinex®

Children's

FREEFROM

MULTI-SYMPTOM

COLD

& STUFFY NOSE

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

GUAIFENESIN – EXPECTORANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

FREEFROM

ARTIFICIAL FLAVORS, COLORS, & DYES • ALCOHOL & SUGAR

HONEY

& BERRY NATURAL FLAVOR

AGES

4+ YRS.

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 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50569-3 (50569-3)

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)
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 at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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

Pediatrician Recommended

DAYTIME

NDC 63824-956-64

Mucinex®

Children's

FREEFROM

MULTI-SYMPTOM

COLD

& STUFFY NOSE

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

GUAIFENESIN – EXPECTORANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

FREEFROM

ARTIFICIAL FLAVORS, COLORS, & DYES • ALCOHOL & SUGAR

HONEY

& BERRY NATURAL FLAVOR

AGES

4+ YRS.

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

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