NDC 68703-370 Mucus-clear Sinus Relief

Belladonna, Hepar Sulph Calc, Kali Bic, Pulsatilla, Sanguinaria, Spigelia Anth

NDC Product Code 68703-370

NDC CODE: 68703-370

Proprietary Name: Mucus-clear Sinus 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: Belladonna, Hepar Sulph Calc, Kali Bic, Pulsatilla, Sanguinaria, Spigelia Anth 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

  • 68703 - Silver Star Brands

NDC 68703-370-59

Package Description: 59 mL in 1 BOTTLE, GLASS

NDC Product Information

Mucus-clear Sinus Relief with NDC 68703-370 is a a human over the counter drug product labeled by Silver Star Brands. The generic name of Mucus-clear Sinus Relief is belladonna, hepar sulph calc, kali bic, pulsatilla, sanguinaria, spigelia anth. The product's dosage form is liquid and is administered via oral form.

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.

Mucus-clear Sinus 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: 09-07-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Mucus-clear Sinus Relief Product Label Images

Mucus-clear Sinus 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 volues of each ingredient: Belladonna 6C, Hepar sulph calc 6C, Kali bic 6C, Pulsatilla 6C, Sanguinaria 6C, Spigelia Anth 6C.

Uses*:

Uses*: Homeopathic remedy for sinus headache relief.*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Warnings: If symptoms persist or worsen, consulta healthcare professional. If pregnant or breastfeeding, ask a health 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: Adults & Children 2+: mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 2 hours until symptoms subside.

Other Safety Information

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

Inactive Ingredients:

Inactive Ingredients: Purified water, USP grain alcohol (20% by volume).

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, ask a health professional before use.

Otc - Purpose

Relieves sinus congestion, pain & headache.

* Please review the disclaimer below.