NDC 70797-304 Dr. Talbots Cough Relief

Bryonia Alba, Drosera Rotundifolia, Ipecacuanha, Phosphorus, Rumex Crispus, Spongia Tosta, Senega. Kali Sulphuricum

NDC Product Code 70797-304

NDC CODE: 70797-304

Proprietary Name: Dr. Talbots Cough Relief 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: Bryonia Alba, Drosera Rotundifolia, Ipecacuanha, Phosphorus, Rumex Crispus, Spongia Tosta, Senega. Kali Sulphuricum 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

  • 70797 - Talbot's Pharmaceuticals Family Products, Llc.

NDC 70797-304-01

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE (70797-304-04)

NDC Product Information

Dr. Talbots Cough Relief with NDC 70797-304 is a a human over the counter drug product labeled by Talbot's Pharmaceuticals Family Products, Llc.. The generic name of Dr. Talbots Cough Relief is bryonia alba, drosera rotundifolia, ipecacuanha, phosphorus, rumex crispus, spongia tosta, senega. kali sulphuricum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Talbot's Pharmaceuticals Family Products, Llc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Dr. Talbots Cough Relief 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.

  • BRYONIA ALBA WHOLE 6 [hp_X]/118mL
  • DROSERA ROTUNDIFOLIA FLOWERING TOP 6 [hp_X]/118mL
  • PHOSPHORUS 12 [hp_X]/118mL
  • RUMEX CRISPUS ROOT 6 [hp_X]/118mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 6 [hp_X]/118mL
  • POLYGALA SENEGA ROOT 6 [hp_X]/118mL
  • IPECAC 6 [hp_X]/118mL
  • POTASSIUM SULFATE 6 [hp_X]/118mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
  • CONCORD GRAPE JUICE (UNII: F7039Q79LP)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Talbot's Pharmaceuticals Family Products, Llc.
Labeler Code: 70797
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: 11-01-2019 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: 12-31-2020 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.

Dr. Talbots Cough Relief Product Label Images

Dr. Talbots Cough Relief 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

Active Ingredients
Bryonia Alba 6X HPUS

Drosera rotundifolia 6X HPUS

Ipecacuanha 6X HPUS

Phosphorus 12X HPUS

Rumex crispus 6X HPUS

Spongia Tosta 6X HPUS

Senega 6X HPUS
Cell Salts
Kali sulphuricum 6X HPUS

Uses

  • UsesTemporarily relievessore throatdry, tickling, mucusy, and/or spasmodic coughs associated with coldschest congestion

Warnings

  • Do not use:for persistent or chronic coughfor treating cough from asthma, smoking, or emphysemafor treating cough with excessive mucusA persistent cough may be a sign of a serious conditionStop use and ask doctor if:cough lasts for more than 7 dayscough comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
  • Please consult your physician immediately for a worsening condition.

Pregnancy Or Breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away.
DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

Directions

  • Shake before use, natural juice may settleMeasure only with the dosing syringe providedDo not use dosing syringe with other productsOn dosing syringe, weight is specific to productOn dosing syringe, ml = milliliter, lbs = pounds, kgs = kilogramsChildren under 6 months of age, consult a medical professional before using this product.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 improveChildren 19 - 29 lbs or 9 - 13 kgs
  • 2.5 ml every 2 hours, reduce frequency when symptoms improveChildren 30 - 90 lbs or 14 - 41 kgs
  • 5 ml every 2 hours, reduce frequency when symptoms improve

Inactive Ingredients

Inactive ingredientsCitric acid, elderberry juice, glycerin, grape juice, potassium sorbate, purified water

Questions

Questions or Comments?Call us at 1-800-588-6227M-F 8am-5pm CST

Purpose

Purpose
Painful cough

Spasmodic cough

Gagging cough

Oppresive cough

Barking cough

Dry cough

Rattling in chest

Rattling of mucus in chest

* Please review the disclaimer below.