Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime Solution
FDA Label NDC 63824-959

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime (NDC 63824-959). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if the child has, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Otc - Purpose

Active ingredients (in each 10 mL)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
Triprolidine HCl 1.25 mgAntihistamine

Uses

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose
    • sneezing
    • cough
    • stuffy nose
    • temporarily reduces fever
    • controls cough to help your child get to sleep

Liver Warning

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

  • more than 1625 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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.

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.

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
  • 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.

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

When Using This Product

  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

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 4 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

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

Questions?

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

You may also report side effects to this phone number.

Principal Display Panel - 118 Ml Bottle Carton

Pediatrician Recommended

NIGHTTIME

NDC 63824-959-64

Mucinex®
Children's

FREEFROM

MULTI-SYMPTOM
COLD & FLU
NIGHTTIME

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
TRIPROLIDINE HCl – ANTIHISTAMINE

FREEFROM
ARTIFICIAL FLAVORS, COLORS, & DYES • ALCOHOL & SUGAR

ELDERBERRY
& CHERRY NATURAL FLAVOR

AGES
6+ YRS.

4 FL OZ (118 mL)

Principal Display Panel (118 mL Bottle Carton)

Principal Display Panel (118 mL Bottle Carton)

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