Mucinex® Children's

Mucinex® Children's
SPL v5
SPL
SPL Set ID e3aea6df-37a4-43c5-a192-a902cbff3f92
Route
ORAL
Published
Effective Date 2020-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg) Acetaminophen (325 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: red Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-21

Description

Day Time Multi-Symptom Cold – Ages 4+ Drug Facts


Medication Information

Description

Day Time Multi-Symptom Cold – Ages 4+ 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

Day Time Multi-Symptom Cold – Ages 4+

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 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) 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
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • 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.
Questions?

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

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Other Information
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

When Using This Product
  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
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.
Principal Display Panel Kit Carton

Pediatrician Recommended

VALUE



PACK

READ ALL INFORMATION

NDC 63824-955-74

MUCINEX®



Children's

DAY TIME



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)

NIGHT TIME



MULTI-SYMPTOM



COLD

Acetaminophen 325 mg – Pain Reliever/Fever Reducer



Diphenhydramine HCl 12.5 mg – Antihistamine/Cough Suppressant



Phenylephrine HCl 5 mg – Nasal Decongestant

  • Relieves Stuffy Nose
  • Controls Cough
  • Relieves Runny Nose & Sneezing
  • Relieves Fever & Sore Throat

Ages



6+



yrs

Very Berry



Flavor Liquid

4 FL OZ (118 mL)

8 FL OZ (236 mL) TOTAL

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
Ask A Doctor Or Pharmacist Before Use If the Child Is
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

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)

Day Time Multi-Symptom Cold – Ages 4+

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 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) 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
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • 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.
Questions?

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

Allergy Alert (Allergy alert)

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

When Using This Product (When using this product)
  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
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.
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Pediatrician Recommended

VALUE



PACK

READ ALL INFORMATION

NDC 63824-955-74

MUCINEX®



Children's

DAY TIME



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)

NIGHT TIME



MULTI-SYMPTOM



COLD

Acetaminophen 325 mg – Pain Reliever/Fever Reducer



Diphenhydramine HCl 12.5 mg – Antihistamine/Cough Suppressant



Phenylephrine HCl 5 mg – Nasal Decongestant

  • Relieves Stuffy Nose
  • Controls Cough
  • Relieves Runny Nose & Sneezing
  • Relieves Fever & Sore Throat

Ages



6+



yrs

Very Berry



Flavor Liquid

4 FL OZ (118 mL)

8 FL OZ (236 mL) TOTAL

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
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)