NDC 50844-400 Severe Congestion And Cough Relief

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 50844-400

NDC CODE: 50844-400

Proprietary Name: Severe Congestion And Cough Relief 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, Phenylephrine Hcl 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):
BLUE (C48333)
Flavor(s):
BERRY (C73365)

NDC Code Structure

  • 50844 - L.n.k. International, Inc.
    • 50844-400 - Severe Congestion And Cough Relief

NDC 50844-400-45

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Severe Congestion And Cough Relief with NDC 50844-400 is a a human over the counter drug product labeled by L.n.k. International, Inc.. The generic name of Severe Congestion And Cough Relief is dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: L.n.k. International, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Severe Congestion And Cough Relief 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL
  • GUAIFENESIN 400 mg/20mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • 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.

Product Labeler Information

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

Labeler Name: L.n.k. International, Inc.
Labeler Code: 50844
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: 03-15-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Severe Congestion And Cough Relief Product Label Images

Severe Congestion And Cough Relief 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 20 Ml)

Dextromethorphan HBr 20 mg Guaifenesin 400 mgPhenylephrine HCl 10 mg

Purpose

Cough suppressant ExpectorantNasal 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:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold

Do Not Use

  • For children under 12 years of ageif 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 diseasediabetes high blood pressure thyroid disease difficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occursymptoms do not get better within 7 days or occur with fevercough comes back or occurs with rash or headache that lasts.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 overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than 6 doses in any 24-hour periodmL = milliliter; FL OZ = fluid ounceuse only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

Other Information

  • Each 20 mL contains: sodium 10 mgTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGuse by expiration date on packagestore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

Anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

* Please review the disclaimer below.