NDC 50594-812 Sound Body Mucus Dm

Dextromethorphan Hydrobromide, Guaifenesin

NDC Product Code 50594-812

NDC Code: 50594-812

Proprietary Name: Sound Body Mucus Dm Additional informationCallout TooltipWhat 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: Dextromethorphan Hydrobromide, Guaifenesin Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
YELLOW (C48330 - LIGHT)
Shape: OVAL (C48345)
Size(s):
22 MM
Imprint(s):
L812
Score: 1

Code Structure
  • 50594 - Big Lots Stores, Inc.
    • 50594-812 - Sound Body Mucus Dm

NDC 50594-812-66

Package Description: 1 BOTTLE in 1 CARTON > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Sound Body Mucus Dm with NDC 50594-812 is a a human over the counter drug product labeled by Big Lots Stores, Inc.. The generic name of Sound Body Mucus Dm is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Big Lots Stores, Inc.

Dosage Form: Tablet, 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.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Sound Body Mucus Dm Active Ingredient(s)

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

  • GUAIFENESIN 1200 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 60 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • COPOVIDONE K25-31 (UNII: D9C330MD8B)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Big Lots Stores, Inc.
Labeler Code: 50594
FDA Application Number: ANDA207602 Additional informationCallout TooltipWhat 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat 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: 03-25-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Sound Body Mucus Dm Product Label Images

Sound Body Mucus Dm 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

Active Ingredients (In Each Extended-Release Tablet)

Dextromethorphan HBr 60 mgGuaifenesin 1200 mg

Purposes

Cough suppressantExpectorant

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 you get to sleep

Do Not Use

  • •for children under 12 years of age •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

  • •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 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.

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

  • •each tablet contains: magnesium 25 mg •do not use if printed foil under cap is broken or missing •store between 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

* Please review the disclaimer below.

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