Dr Talbots Infant Cough Relief

Antimonium Tartaricum 12x,drosera Rotundifolia 12x,ipecacuanha 12x,phosphorus 12x,rumex Crispus 12x,spongia Tosta 12x,sticta Pulmonaria 12x,kali Sulphuricum 6x


Talbots Pharmaceuticals Family Products, Llc.
Human Otc Drug
NDC 70797-319
Dr Talbots Infant Cough Relief also known as Antimonium Tartaricum 12x,drosera Rotundifolia 12x,ipecacuanha 12x,phosphorus 12x,rumex Crispus 12x,spongia Tosta 12x,sticta Pulmonaria 12x,kali Sulphuricum 6x is a human otc drug labeled by 'Talbots Pharmaceuticals Family Products, Llc.'. National Drug Code (NDC) number for Dr Talbots Infant Cough Relief is 70797-319. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Dr Talbots Infant Cough Relief drug includes Antimony Tartrate Ion - 12 [hp_X]/118mL Drosera Rotundifolia Flowering Top - 12 [hp_X]/118mL Ipecac - 12 [hp_X]/118mL Phosphorus - 12 [hp_X]/118mL Pulmonaria Officinalis Whole - 12 [hp_X]/118mL Rumex Crispus Root - 12 [hp_X]/118mL Spongia Officinalis Skeleton, Roasted - 12 [hp_X]/118mL . The currest status of Dr Talbots Infant Cough Relief drug is Active.

Drug Information:

Drug NDC: 70797-319
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: Dr Talbots Infant Cough Relief
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: Antimonium Tartaricum 12x,drosera Rotundifolia 12x,ipecacuanha 12x,phosphorus 12x,rumex Crispus 12x,spongia Tosta 12x,sticta Pulmonaria 12x,kali Sulphuricum 6x
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Talbots Pharmaceuticals Family Products, Llc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:ANTIMONY TARTRATE ION - 12 [hp_X]/118mL
DROSERA ROTUNDIFOLIA FLOWERING TOP - 12 [hp_X]/118mL
IPECAC - 12 [hp_X]/118mL
PHOSPHORUS - 12 [hp_X]/118mL
PULMONARIA OFFICINALIS WHOLE - 12 [hp_X]/118mL
RUMEX CRISPUS ROOT - 12 [hp_X]/118mL
SPONGIA OFFICINALIS SKELETON, ROASTED - 12 [hp_X]/118mL
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: 12 Sep, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 May, 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:Talbots Pharmaceuticals Family Products, LLC.
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.
UPC:0370797300134
UPC stands for Universal Product Code.
UNII:CQN5KB2U1M
75O014T1HG
62I3C8233L
27YLU75U4W
483B0A2Y00
9N1RM2S62C
1PIP394IID
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
70797-319-011 BOTTLE in 1 CARTON (70797-319-01) / 118 mL in 1 BOTTLE12 Sep, 2022N/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:

Purpose temporarily relieves: dry cough sore throat from cough mucus buildup & cough chest congestion purpose

Product Elements:

Dr talbots infant cough relief antimonium tartaricum 12x,drosera rotundifolia 12x,ipecacuanha 12x,phosphorus 12x,rumex crispus 12x,spongia tosta 12x,sticta pulmonaria 12x,kali sulphuricum 6x glycerin ipecac ipecac pulmonaria officinalis whole pulmonaria officinalis whole phosphorus phosphorus water european elderberry juice citric acid monohydrate antimony tartrate ion antimony tartrate ion spongia officinalis skeleton, roasted spongia officinalis skeleton, roasted rumex crispus root rumex crispus root drosera rotundifolia flowering top drosera rotundifolia flowering top potassium sorbate concord grape juice

Indications and Usage:

Usage uses temporarily relieves sore throat chest congestion dry, ticking, mucusy, and/or spasmodic coughs associated with colds uses

Warnings:

Warnings warnings do not use: for persistent or chronic cough for treating cough from asthama, smoking, or emphysema for treating cough with excessive mucus a persistent cough may be a sign of a serious condition warning

Dosage and Administration:

Dosage children under 6 months of age , consult a medical professional before using this product.(see attched product image) for sudden onset of symptoms: use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter. children 6 - 18 lbs or 3 - 8 kgs 1.25 ml every 2 hours, reduce frequency when symptoms improve children 19 - 29 lbs or 9 - 13 kgs 2.5 ml every 2 hours, reduce frequency when symptoms improve children 30 - 90 lbs or 14 - 41 kgs 5 ml every 2 hours, reduce frequency when symptoms improve dosage

Package Label Principal Display Panel:

Principal display principal display panel pricipal package display

Further Questions:

Question questions questions or comments?(see attched product label image) query


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.