NDC 70797-303 Dr. Talbots Mucus Cold Relief

Bryonia Alba, Hepar Sulphuris Calcareum, Kali Bichromicum, Marrubium Vulgare, Phosphorus, Pulsatilla, Rumex Crispus, Sambucus Nigra, Calcarea Sulphurica, Ferrum Phosphoricum, Kali Muriaticum

NDC Product Code 70797-303

NDC CODE: 70797-303

Proprietary Name: Dr. Talbots Mucus Cold 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, Hepar Sulphuris Calcareum, Kali Bichromicum, Marrubium Vulgare, Phosphorus, Pulsatilla, Rumex Crispus, Sambucus Nigra, Calcarea Sulphurica, Ferrum Phosphoricum, Kali Muriaticum 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with water pills/diuretics.

NDC Code Structure

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

NDC 70797-303-01

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE (70797-303-04)

NDC Product Information

Dr. Talbots Mucus Cold Relief with NDC 70797-303 is a a human over the counter drug product labeled by Talbot's Pharmaceuticals Family Products, Llc.. The generic name of Dr. Talbots Mucus Cold Relief is bryonia alba, hepar sulphuris calcareum, kali bichromicum, marrubium vulgare, phosphorus, pulsatilla, rumex crispus, sambucus nigra, calcarea sulphurica, ferrum phosphoricum, kali muriaticum. 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 Mucus Cold 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.

  • SAMBUCUS NIGRA FLOWERING TOP 6 [hp_X]/118mL
  • CALCIUM SULFATE ANHYDROUS 6 [hp_X]/118mL
  • POTASSIUM CHLORIDE 6 [hp_X]/118mL
  • BRYONIA ALBA WHOLE 6 [hp_X]/118mL
  • MARRUBIUM VULGARE 6 [hp_X]/118mL
  • PHOSPHORUS 30 [hp_X]/118mL
  • RUMEX CRISPUS ROOT 6 [hp_X]/118mL
  • CALCIUM SULFIDE 12 [hp_X]/118mL
  • POTASSIUM DICHROMATE 12 [hp_X]/118mL
  • ANEMONE PULSATILLA 6 [hp_X]/118mL
  • FERROSOFERRIC PHOSPHATE 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.

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

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 Mucus Cold Relief Product Label Images

Dr. Talbots Mucus Cold 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

Hepar sulphuris calcareum 12X HPUS

Kali bichromicum 12X HPUS

Marrubium vulgare 6X HPUS

Phosphorus 30X HPUS

Pulsatilla 6X HPUS

Rumex crispus 6X HPUS

Sambucus nigra 6x HPUS
Cell Salts
Calcarea sulphurica 6X HPUS

Ferrum phosphoricum 6X HPUS

Kali muriaticum 6X HPUS

Purpose

Purpose
Stubborn mucus, chest soreness

Yellowish mucus discharge
Sinus congestion

Cough with expectoration

Chest congestion

Discharge of thick yellowish mucus

Copious mucus discharge

Nasal congestion

Thick mucus yellowish discharges

Congestion and inflammation of mucus membranes

Inflammation with discharge

Uses

  • UsesTemporarily relievesmucusy coughcough and congestion associated with coldsnasal and sinus congestionmucus in chestsneezingrunny nose

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/congestion lasts for more than 7 days.cough/congestion comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious confition.other symptoms persist for more than 7 days or worsenAsk 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, glycerin, grape juice, potassium sorbate, purified water

Questions

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

* Please review the disclaimer below.