NDC 68703-345 Cough And Cold Relief

Arg Met, Arsenicum Alb, Baptisia, Bryonia, Causticum, Dulcamara, Echinacea Angustifolia, Echinacea Purp, Kali Bic, Merc Coros, Phos, Pulsatilla Nutt, Senega, Zinc Pic, Zinc Val

NDC Product Code 68703-345

NDC CODE: 68703-345

Proprietary Name: Cough And 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: Arg Met, Arsenicum Alb, Baptisia, Bryonia, Causticum, Dulcamara, Echinacea Angustifolia, Echinacea Purp, Kali Bic, Merc Coros, Phos, Pulsatilla Nutt, Senega, Zinc Pic, Zinc Val 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.

  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
  • 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

  • 68703 - Silver Star Brands

NDC 68703-345-02

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Cough And Cold Relief with NDC 68703-345 is a a human over the counter drug product labeled by Silver Star Brands. The generic name of Cough And Cold Relief is arg met, arsenicum alb, baptisia, bryonia, causticum, dulcamara, echinacea angustifolia, echinacea purp, kali bic, merc coros, phos, pulsatilla nutt, senega, zinc pic, zinc val. The product's dosage form is spray and is administered via oral form.

Labeler Name: Silver Star Brands

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Cough And 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.

  • ECHINACEA ANGUSTIFOLIA 10 [hp_X]/59mL
  • POLYGALA SENEGA ROOT 10 [hp_X]/59mL
  • PHOSPHORUS 10 [hp_X]/59mL
  • ZINC PICRATE 10 [hp_X]/59mL
  • ZINC VALERATE 10 [hp_X]/59mL
  • MERCURIC CHLORIDE 10 [hp_X]/59mL
  • ARSENIC TRIOXIDE 10 [hp_X]/59mL
  • POTASSIUM DICHROMATE 10 [hp_X]/59mL
  • BAPTISIA TINCTORIA 10 [hp_X]/59mL
  • CAUSTICUM 10 [hp_X]/59mL
  • ECHINACEA PURPUREA 10 [hp_X]/59mL
  • ANEMONE PATENS WHOLE 10 [hp_X]/59mL
  • POTASSIUM CHLORIDE 10 [hp_X]/59mL
  • SILVER 10 [hp_X]/59mL
  • SOLANUM DULCAMARA FLOWER 10 [hp_X]/59mL

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.

  • CARYA OVATA BARK (UNII: X765CF609L)
  • BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)
  • WATER (UNII: 059QF0KO0R)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLUCOSYL STEVIOL (UNII: TKD5UC898Q)

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: Silver Star Brands
Labeler Code: 68703
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: 10-01-2019 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: 12-31-2021 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.

Cough And Cold Relief Product Label Images

Cough And 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

Hpus Active Ingredients

HPUS Active Ingredients: Equal volumes of each ingredientin 10X, 30x, 1LM potencies; Arg met, Arsenicum alb, Baptisia, Bryonia, Causticum, Dulcamara, Echinacea angustifolia, Echinacea purp, Kali bic, kali mur, merc corros, Phos, Pulsatilla nutt, Senega, zinc pic, Zinc val.

Uses*

Temporarily relieves symptoms contributing to congestion, coughs, sneezing, headaches, fever & chills. *This statement has not been evaluated by the Food and drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings

Warnings:If symptom spersist or worsen, consult a healthcare professional.
If pregnant or breastfeeding, ask a healthcare professional before use.
Keep this and all medication out of reach of children. in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and Children 12+: 3 sprays, 3 times per day. childeren 2-12: 2 sprays, 3 times perday. Use additionally as needed, up to 6 times per day.

Other Safety Information

Contains no artificial flavors or colorants. No gluten added. Tamper resistant for your protection. Use only if saftey seal is intact.

Inactive Ingredients

Inactive ingredients: Purified water, carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, as ka healthcare professional before use.

Otc - Purpose

Congestion, Cough, Sneezing, Headaches, Fever & Chills.

* Please review the disclaimer below.