NDC 0363-1604 Mucus Relief D
Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release Oral

Product Information

Mucus Relief D is a human over the counter drug product labeled by Walgreens Company. The generic name of Mucus Relief D is guaifenesin and pseudoephedrine hcl. The product's dosage form is tablet, extended release and is administered via oral form.

Product Code0363-1604
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.
Mucus Relief D
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 Pseudoephedrine Hcl
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 FormTablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
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.
Walgreens Company
Labeler Code0363
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.
ANDA208369
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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.
08-13-2019
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.
12-31-2022
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

What are the uses for Mucus Relief D?


Product Characteristics

Color(s)ORANGE (C48331)
ShapeCAPSULE (C48336)
Size(s)22 MM
Imprint(s)RDY;799
Score1

Product Packages

NDC 0363-1604-15

Package Description: 1 BLISTER PACK in 1 CARTON > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 0363-1604-20

Package Description: 2 BLISTER PACK in 1 CARTON > 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 0363-1604-37

Package Description: 2 BLISTER PACK in 1 CARTON > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 0363-1604-40

Package Description: 4 BLISTER PACK in 1 CARTON > 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Product Details

What are Mucus Relief D Active Ingredients?

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.
  • GUAIFENESIN 600 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
  • PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

Mucus Relief D Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1305603 - guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1305603 - 12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet
  • RxCUI: 1305603 - guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral Tablet

Mucus Relief D Inactive Ingredients UNII Codes

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.

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

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]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Mucus Relief D 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



Active Ingredients (In Each Extended-Release Tablet)



Guaifenesin USP, 600 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant 


Purpose



Expectorant and Nasal Decongestant


Uses



  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure

Warnings




Do Not Use



if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease

  • diabetes

  • trouble urinating due to an enlarged prostate gland

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • cough accompanied by too much phlegm (mucus)


When Using This Product



  • do not use more than directed

Stop Use And Ask Doctor If



  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information



  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store between 20° - 25°C (68° - 77°F)

Inactive Ingredients



FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.


Questions?



call 1-888-375-3784

You may also report side effect to this phone number.


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* Please review the disclaimer below.