NDC 0220-9347 Sinuscalm

Atropa Belladonna, Sanguinaria Canadensis Root, Spigelia Anthelmia

NDC Product Code 0220-9347

NDC 0220-9347-42

Package Description: 1 TUBE in 1 BOX > 80 PELLET in 1 TUBE (0220-9347-41)

NDC Product Information

Sinuscalm with NDC 0220-9347 is a a human over the counter drug product labeled by Boiron. The generic name of Sinuscalm is atropa belladonna, sanguinaria canadensis root, spigelia anthelmia. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Boiron

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Sinuscalm 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.

  • ATROPA BELLADONNA 3 [hp_C]/1
  • SANGUINARIA CANADENSIS ROOT 3 [hp_C]/1
  • SPIGELIA ANTHELMIA 3 [hp_C]/1

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.

  • SUCROSE (UNII: C151H8M554)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

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: Boiron
Labeler Code: 0220
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: 12-01-2019 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.

Sinuscalm 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

Otc - Active Ingredient

Belladonna 3C HPUS (0.14 mg), Sanguinaria canadensis 3C HPUS (0.14 mg), Spigelia anthelmia 3C HPUS(0.14 mg) **

(in each pellet)

Otc - Purpose

Belladonna 3C HPUS Relieves sinus pain and stuffy nose(contains less than 10-10 mg alkaloids per pellet)Sanguinaria canadensis 3C HPUS Relieves sinus pain with runny hose(contains less than 10-9 mg alkaloids per pellet)Spigelia anthelmia 3C HPUS Relieves sinus pain with postnasal dripThe letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Temporarily relieves sinus symptoms due to the common cold or allergies such as: nasal congestion, sinus pain, headache

Otc - Ask Doctor

Stop use and ask a doctor if symptoms persist for more than 3 days, worsen, or are accompanied by a fever.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Adults and children 6 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 2 hours up to 6 times a day until symptoms are relieved. Children under 6 years of age: Ask a doctor.

Other

Do not use if pellet dispenser seal is broken.

Contains approx 80 quick dissolving pellets per tube.

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
Formally Sinusalia

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Inactive Ingredient

Lactose, sucrose

Otc - Questions

1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com Info@boiron.com

Distributed by Boiron, Inc. Newtown Square, PA 19073
Made in France

* Please review the disclaimer below.