mucinex® children's day time multi-symptom cold and mucinex® children's night time multi-symptom cold triple pack

mucinex® children's day time multi-symptom cold and mucinex® children's night time multi-symptom cold triple pack
SPL v3
SPL
SPL Set ID c7ab5201-8550-4bf4-957c-c8f049aeaa4a
Route
oral
Published
Effective Date 2022-05-26
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 2022-05-25

Description

Drug Facts


Medication Information

Uses
  • temporarily relieves these common cold and flu symptoms
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose
    • sneezing
    • cough
  • controls cough to help your child get to sleep
  • temporarily reduces fever
Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use
Other Information
  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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

Description

Drug Facts

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not use more than directed

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 10 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
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.
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.

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.

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
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Principal Display Panel Kit Carton

Pediatrician Recommended

TRIPLE

PACK

NDC 63824-944-34

READ ALL INFORMATION

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

THREE – 4 FL OZ (118mL)

NIGHT TIME

MULTI-SYMPTOM

COLD

Acetaminophen 325 mg–Pain Reliever/Fever Reducer

Diphenhydramine HCl 12.5–Antihistamine/

Cough Suppressant

Phenylephrine HCl mg–Nasal Decongestant

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

Ages

6 +yrs

Very Berry

Flavor Liquid

TOTAL – 12 FL OZ (354mL)

Ask A Doctor Before Use If the Child Has
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
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
  • temporarily relieves these common cold and flu symptoms
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose
    • sneezing
    • cough
  • controls cough to help your child get to sleep
  • temporarily reduces fever
Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use
Other Information (Other information)
  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not use more than directed

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 10 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
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.
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.

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.

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
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Pediatrician Recommended

TRIPLE

PACK

NDC 63824-944-34

READ ALL INFORMATION

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

THREE – 4 FL OZ (118mL)

NIGHT TIME

MULTI-SYMPTOM

COLD

Acetaminophen 325 mg–Pain Reliever/Fever Reducer

Diphenhydramine HCl 12.5–Antihistamine/

Cough Suppressant

Phenylephrine HCl mg–Nasal Decongestant

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

Ages

6 +yrs

Very Berry

Flavor Liquid

TOTAL – 12 FL OZ (354mL)

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
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

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