NDC 68466-2010 Cough And Bronchial Childrens Syrup

Antimony Pentasulfide, Bryonia Alba Root, Drosera Rotundifolia, Eucalyptus Globulus Leaf, Ipecac, Illicium Anisatum Whole

NDC Product Code 68466-2010

NDC CODE: 68466-2010

Proprietary Name: Cough And Bronchial Childrens Syrup 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: Antimony Pentasulfide, Bryonia Alba Root, Drosera Rotundifolia, Eucalyptus Globulus Leaf, Ipecac, Illicium Anisatum Whole 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.

NDC Code Structure

NDC 68466-2010-5

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 118 mL in 1 BOTTLE, PLASTIC

NDC 68466-2010-9

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 237 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cough And Bronchial Childrens Syrup with NDC 68466-2010 is a a human over the counter drug product labeled by Schwabe Mexico S.a. De C.v.. The generic name of Cough And Bronchial Childrens Syrup is antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, illicium anisatum whole. The product's dosage form is syrup and is administered via oral; oral form.

Dosage Form: Syrup - 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.

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.

Cough And Bronchial Childrens Syrup 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.

  • ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ALCOHOL (UNII: 3K9958V90M)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Schwabe Mexico S.a. De C.v.
Labeler Code: 68466
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 10-14-2021 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.

Cough And Bronchial Childrens Syrup Product Label Images

Cough And Bronchial Childrens Syrup 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

Antimonium sulphuratum aureum 6XBryonia 3XDrosera 4XEucalyptus globulus 3XIllicium verum 3XIpecacuanha 4X

Inactive Ingredients

Aronia JuiceCitric AcidEthyl AlcoholFructoseNatural flavorPotassium SorbatePurified Water

Dosage & Administration

Shake well before use.Children 6 to 12 Years: Take 2 teaspoons (tsp) (10mL) every 2 hours.For severe coughs, repeat every 20 minutes for first hour, then every 2 hours.Children under 6 years of age: Consult a doctor.

Purpose

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

Indications & Usage

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

Warning

Do not use this product for children with persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus).

Ask Doctor

Ask a doctor before use if your child has a persistent or chronic cough that lasts, is chronic such as occurrs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus).

Stop Use

New symptoms occur, symptoms worsen, or do not get better within 7 days, if cough is accompanied by fever, rash or persistent headache.These could be signs of a serious conditions.

Pregnant Or Breast-Feeding

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

Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of overdosage, seek medical help or contact a Posion Control Center Immediately.

* Please review the disclaimer below.