NDC 47682-345 Mediqe Medi-mucus

Dextromethorphan Hbr, Guaifenesin

NDC Product Code 47682-345

NDC Code: 47682-345

Proprietary Name: Mediqe Medi-mucus 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: Dextromethorphan Hbr, Guaifenesin 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
16 MM
Imprint(s):
AZ;345
Score: 2

NDC Code Structure

NDC 47682-345-46

Package Description: 1 TABLET in 1 PACKET

NDC 47682-345-50

Package Description: 50 PACKET in 1 BOX > 1 TABLET in 1 PACKET

NDC Product Information

Mediqe Medi-mucus with NDC 47682-345 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Mediqe Medi-mucus is dextromethorphan hbr, guaifenesin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Mediqe Medi-mucus 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.

  • GUAIFENESIN 200 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1

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.

  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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.

Labeler Name: Unifirst First Aid Corporation
Labeler Code: 47682
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: 06-03-2019 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: 12-31-2020 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.

Mediqe Medi-mucus Product Label Images

Mediqe Medi-mucus 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 Tablet)

Dextromethorphan HBr 20 mgGuaifenesin 400 mg

Purpose

Cough suppressantExpectorant

Uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productiveTemporarily relieves:■ cough due to minor throat irritations as may occur with the common cold or inhaled irritants■ the intensity of coughing■ the impulse to cough to help you get sleep

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. complete

Ask A Doctor Before Use If You Have

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema■ cough that occurs with excessive phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking sedatives or tranquilizers

When Using This Product

■ do not use more than directed

Stop Use And Ask A Doctor If

■ cough lasts for more than 7 days, comes back or occurs with fever, rash or persistent headache.These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children:(12 years and older)Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.Children under 12 yearsDo not use.

Other Information

■ store at room temperature 68º-77ºF (20º-25ºC)■ keep in a dry place and do not expose to heat■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredients

Croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Medique Medi-Mucus Label

Collect MediBucksSee inside flap for more detailsMedique®Medi-MucusControls CoughsThins & Loosens MucusPull To Open✓ Cough Supressant • Dextromethorphan HBr 20mg✓ Expectorant • Guaifenesin 400mg50 Tablets(50 x 1)Tamper Evident Unit Dose Packets

* Please review the disclaimer below.