NDC 70242-103 Broncomar Maximun Cough Relief

Dextromethorphan Hbr, Guaifenesin

NDC Product Code 70242-103

NDC 70242-103-06

Package Description: 1 BOTTLE in 1 CARTON > 177 mL in 1 BOTTLE

NDC Product Information

Broncomar Maximun Cough Relief with NDC 70242-103 is a a human over the counter drug product labeled by Dannso Corp./d.b.a. Essential Products. The generic name of Broncomar Maximun Cough Relief is dextromethorphan hbr, guaifenesin. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1234473.

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.

Broncomar Maximun 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Dannso Corp./d.b.a. Essential Products
Labeler Code: 70242
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: 10-01-2001 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: 12-31-2021 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.

Information for Patients

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]

* Please review the disclaimer below.

Broncomar Maximun Cough Relief Product Label Images

Broncomar Maximun 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

Otc - Active Ingredient

Active Ingredients:(in each 10 ml.)PurposeDextromethorphan Hydrobromide 30 mg ....................Cough SuppressantGuaifenesin 200 mg.......................................................Expectorant

Otc - Purpose

  • Uses:Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

Warnings

WarningsDo not exceed recommended dosage

Otc - Do Not Use

  • Do not useIf you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.Avoid alcoholic beverage while taking this product.Stop use and ask a doctorNervousness, dizziness or sleeplessness occurs.Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.

Otc - Ask Doctor

  • Ask doctor before use if you have
  • Cough that occurs with too much phlegm(mucus)
  • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health professional before use.

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.

Dosage & Administration

  • DirectionsDo not exceed 6 doses in any 24 hour period.
  • AGEDOSEAdults and Children 12 years and over10 ml (2 tsps) every 6 hoursChildren 6 to under 12 years of age5 ml (1 tsp) every 6 hoursChildren under 6 years of ageDo not  use

Indications & Usage

  • Other Information:Each 10 mls contains: sodium 4 mgStore between 15 - 30 degrees Celsius (59 - 86 Fahrenheit). Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Glycerin, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

* Please review the disclaimer below.