NDC 53499-8393 Childrens Cough And Bronchial

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

NDC Product Code 53499-8393

NDC CODE: 53499-8393

Proprietary Name: Childrens Cough And Bronchial 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 53499-8393-5

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

NDC 53499-8393-9

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

NDC Product Information

Childrens Cough And Bronchial with NDC 53499-8393 is a a human over the counter drug product labeled by Schwabe North America, Inc. The generic name of Childrens Cough And Bronchial 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 form.

Labeler Name: Schwabe North America, Inc

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.

Childrens Cough And Bronchial 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.

  • ANTIMONY PENTASULFIDE 6 [hp_X]/237mL
  • BRYONIA ALBA ROOT 3 [hp_X]/237mL
  • DROSERA ROTUNDIFOLIA FLOWERING TOP 4 [hp_X]/237mL
  • EUCALYPTUS GLOBULUS LEAF 3 [hp_X]/237mL
  • IPECAC 4 [hp_X]/237mL
  • ILLICIUM ANISATUM WHOLE 3 [hp_X]/237mL

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: Schwabe North America, Inc
Labeler Code: 53499
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-18-2017 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 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.

Childrens Cough And Bronchial Product Label Images

Childrens Cough And Bronchial 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:  Antimonium sulphuratum aureum 6XBryonia 3XDrosera rotundifolia 3XEucalyptus globulus 3XIllicium anisatum 3XIpecacuanha 4X

Inactive Ingredient

Inactive Ingredients:Aronia JuiceCitric AcidEthyl Alcohol (1%)FructoseNatural Cherry flavorPotassium SorbatePurified Water

Dosage & Administration

Dosage and Administration:Shake well before use.Children 6 to 12 Years:  two teaspoons (10mL) every two hours.For severe coughs, repeat every 20 minutes for first hour, then every two hours.Children under 6 years of age:  Consult a Physician

Otc - Purpose

OTC Purpose: Temporarily relieves coughs due to minor throat and bronchial irritations as may occur with a cold.Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.Soothes the throat.

Indications & Usage

Indications and Usage:Temporarily relieves coughs due to minor throat and bronchial irritations as may occur with a cold.Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.Soothes the throat.

Warnings

Sore Throat WarningSevere or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serious.Consult a physician promptly.

Otc - Ask Doctor

Ask a doctor before use if you have: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).

Otc - Stop Use

Stop use and ask a doctor if:New symptoms occur, symptoms worsen, or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache. These could be signs of a serious conditions.

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children:Keep out of reach of children.

Overdosage

Overdose:In case of overdose, seek medical help or contact a Poison Control Center immediately.

Otc - Pregnancy Or Breast Feeding

Pregnant of Breast-feeding:If pregnant or breast-feeding, ask a healthcare porfessional before use.

* Please review the disclaimer below.