NDC 68466-1009 Cough And Bronchial Nighttime Syrup
Aconitum Napellus, Bryonia Root, Calcium Cation, Spongia Officinalis Skeleton, Roasted...

Product Information

What is NDC 68466-1009?

The NDC code 68466-1009 is assigned by the FDA to the product Cough And Bronchial Nighttime Syrup which is a human over the counter drug product labeled by Schwabe Mexico S.a. De C.v.. The generic name of Cough And Bronchial Nighttime Syrup is aconitum napellus, bryonia root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean. The product's dosage form is syrup and is administered via oral; oral form. The product is distributed in 2 packages with assigned NDC codes 68466-1009-5 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic, 68466-1009-9 1 bottle, plastic in 1 carton / 240 ml in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code68466-1009
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.		Cough And Bronchial Nighttime Syrup
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.		Aconitum Napellus, Bryonia Root, Calcium Cation, Spongia Officinalis Skeleton, Roasted, Tin, Medicago Sativa Leaf, Oat, Arabica Coffee Bean
Substance Name What is the Substance Name?
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.		Aconitum Napellus; Arabica Coffee Bean; Bryonia Alba Root; Calcium Sulfide; Medicago Sativa Leaf; Oat; Spongia Officinalis Skeleton, Roasted; Tin
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 FormSyrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
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.
  • 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.		Schwabe Mexico S.a. De C.v.
Labeler Code68466
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.		UNAPPROVED HOMEOPATHIC -
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.		03-03-2023
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.		12-31-2024
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 Cough And Bronchial Nighttime Syrup?


Product Packages

NDC Code 68466-1009-5

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC

NDC Code 68466-1009-9

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC

Product Details

What are Cough And Bronchial Nighttime Syrup 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.

Cough And Bronchial Nighttime Syrup Active Ingredients UNII Codes

Cough And Bronchial Nighttime Syrup 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.

* Please review the disclaimer below.

Cough And Bronchial Nighttime Syrup Product Label

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.

Product Label Table of Contents



Active Ingredient



Acontinum napellus 3X

Alfalfa 1X 

Coffea cruda 6X 

Avena sativa 1X 

Bryonia 3X

Hepar sulphuris calcareum 6C 

Spongia tosta 3X 

Stannum metallicum 6C 


Inactive Ingredient



citric acid

ethyl alcohol

malt extract

purified water

sodium benzoate

sucrose


Dosage & Administration



Directions

Shake well before each use.

Adults & children 12 years of age and older: Take 2 teaspoons (tsp) (10mL) 1/2 hour before bedtime. Dose may be repeated if necessary.

Children under 12 years of age: consult a doctor


Indications & Usage



Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.


Purpose



Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.


Warnings



Sore Throat Warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Ask A Doctor



Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications.


Stop Use



Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough last more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition. 


Pregnancy Or Breast Feeding



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


Keep Out Of The Reach Of Children



Keep out of the reach of children.


Overdose



In case of overdose, seek medical help or contact a Poison Control Center right away.


* Please review the disclaimer below.