NDC 63868-771 Childrens Mucus And Cough Relief
Guaifenesin And Dextromethorphan Hydrobromide Liquid Oral

Product Information

Product Code63868-771
Proprietary Name 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.
Childrens Mucus And Cough Relief
Non-Proprietary Name 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.
Guaifenesin And Dextromethorphan Hydrobromide
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Chain Drug Manufacturing Assn
Labeler Code63868
FDA Application Number 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.
part341
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-19-2015
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)RED (C48326)
Flavor(s)CHERRY (C73375)

Product Packages

NDC 63868-771-04

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

Product Details

Childrens Mucus And Cough Relief is a human over the counter drug product labeled by Chain Drug Manufacturing Assn. The generic name of Childrens Mucus And Cough Relief is guaifenesin and dextromethorphan hydrobromide. The product's dosage form is liquid and is administered via oral form.


What are Childrens Mucus And Cough Relief Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


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Patient Education

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]

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Childrens Mucus And Cough Relief Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Otc - Purpose



Active ingredients (in each 5 mL)

Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant


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

Otc - Do Not Use



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.


Otc - Ask Doctor



Ask a doctor before use if the child has

  • •cough that occurs with too much phlegm (mucus)
  • •persistent or chronic cough such as occurs with asthma

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Directions



  • •do not take more than 6 doses in any 24-hour period
  • •measure only with dosing cup provided
  • •do not use dosing cup with other products
  • •mL = milliliter
  • AgeDose

    children 6 years to under 12 years

    5 mL – 10 mL every 4 hours

    children 4 years to under 6 years

    2.5 mL – 5 mL every 4 hours

    children under 4 years

    do not use


Other Information



  • •each 5 mL contains: sodium 3 mg
  • •Tamper -evident: do not use if printed inner seal under cap is torn or missing
  • •store at room temperature
  • •do not refrigerate
  • •dosing cup provided

Inactive Ingredients



Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum


Principal Display Panel - 118 Ml Bottle Carton



NDC 63868-771-04

Compare to the Active ingredient in Children’s Mucinex Cough*

Children's

Mucus &Cough Relief

Cough Suppressant

Expectorant

Dextromethorphan HBr

Guaifenesin

Each Dose of Cherry Flavored

Children's

Mucus & Cough Relief:

Controls Cough
Relieves Chest Congestion
Breaks up Mucus


Alcohol-free

See New Dosing information

Cherry
Flavor

4 FL OZ
(118 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

Distributed by C.D.M.A., Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.®

QC 100% Satisfaction Guaranteed.


* Please review the disclaimer below.