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

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride

NDC Product Code 63824-959

NDC CODE: 63824-959

Proprietary Name: Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

NDC Code Structure

  • 63824 - Rb Health (us) Llc
    • 63824-959 - Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime

NDC 63824-959-64

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime with NDC 63824-959 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime is acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Rb Health (us) Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 325 mg/10mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
  • TRIPROLIDINE HYDROCHLORIDE 1.25 mg/10mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CARMINIC ACID (UNII: CID8Z8N95N)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rb Health (us) Llc
Labeler Code: 63824
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime Product Label Images

Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

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

Otc - Purpose

Active ingredients (in each 10 mL)PurposesAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan HBr 10 mgCough suppressantPhenylephrine HCl 5 mgNasal decongestantTriprolidine HCl 1.25 mgAntihistamine

Uses

  • Temporarily relieves these common cold and flu symptoms:minor aches and painsheadachesore throatnasal congestionrunny nosesneezingcoughstuffy nosetemporarily reduces fevercontrols 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 amountwith other drugs containing acetaminophen

Allergy Alert

  • Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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 sleepyin 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 diseaseheart diseasediabeteshigh blood pressurethyroid diseaseglaucomaa breathing problem such as chronic bronchitispersistent or chronic cough such as occurs with asthmacough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If The Child Is

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Do not use more than directed (see Overdose warning)excitability may occur, especially in childrenmay cause marked drowsinesssedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurpain, nasal congestion, or cough gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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 usedo not give more than directed (see Overdose warning)measure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorchildren 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 periodchildren under 6 years of age: do not use

Other Information

  • Each 10 mL contains: sodium 6 mgstore 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.

* Please review the disclaimer below.