Bronchial Cough

Potassium Dichromate,rumex Crispus Root And Sanguinaria Canadensis Root


Hyland's Inc.
Human Otc Drug
NDC 54973-3222
Bronchial Cough also known as Potassium Dichromate,rumex Crispus Root And Sanguinaria Canadensis Root is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Bronchial Cough is 54973-3222. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Bronchial Cough drug includes Potassium Dichromate - 6 [hp_X]/1 Rumex Crispus Root - 6 [hp_X]/1 Sanguinaria Canadensis Root - 6 [hp_X]/1 . The currest status of Bronchial Cough drug is Active.

Drug Information:

Drug NDC: 54973-3222
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Bronchial Cough
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Potassium Dichromate,rumex Crispus Root And Sanguinaria Canadensis Root
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:POTASSIUM DICHROMATE - 6 [hp_X]/1
RUMEX CRISPUS ROOT - 6 [hp_X]/1
SANGUINARIA CANADENSIS ROOT - 6 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 21 Jan, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Hyland's Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:T4423S18FM
9N1RM2S62C
N9288CD508
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
54973-3222-11 BOTTLE, PLASTIC in 1 CARTON (54973-3222-1) / 100 TABLET in 1 BOTTLE, PLASTIC21 Jan, 2015N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Natural relief for coughs with mucus due to cold

Product Elements:

Bronchial cough potassium dichromate,rumex crispus root and sanguinaria canadensis root acacia lactose monohydrate anhydrous lactose potassium dichromate dichromate ion rumex crispus root rumex crispus root sanguinaria canadensis root sanguinaria canadensis root to off-white

Indications and Usage:

Uses relief of symptoms of cough due to common cold, especially coughs with mucus production and a sensation of tickling in the throat.

Warnings:

Stop use and ask a doctor if:  • symptoms persist for more than 7 days or worsen • cough persists for more than 7 days, tends to recur, or is accompanied by a rash, persistent headache, fever that lasts for more than three days or if new symptoms occur do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center immediately. in case of emergency in case of emergency, contact a medical professional or poison control center immediately.

Dosage and Administration:

Directions adults and children 12 years and over: dissolve 2-3 tablets under tongue every 4 hours or as needed. children 6-12 years of age: 1/2 adult dose.

Stop Use:

Stop use and ask a doctor if:  • symptoms persist for more than 7 days or worsen • cough persists for more than 7 days, tends to recur, or is accompanied by a rash, persistent headache, fever that lasts for more than three days or if new symptoms occur

Package Label Principal Display Panel:

Principal display panel-100 tablet bottle carton ndc 54973-3222-1 hyland's ® homeopathic bronchial cough natural relief for coughs with mucus due to cold* 100 tablets carton

Further Questions:

Questions or comments? (800) 624-9659


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.