NDC 0220-9338 Sinuscalm

Atropa Belladonna, Sanguinaria Canadensis Root, Spigelia Anthelmia

NDC Product Code 0220-9338

NDC Code: 0220-9338

Proprietary Name: Sinuscalm 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: Atropa Belladonna, Sanguinaria Canadensis Root, Spigelia Anthelmia 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
BOIRON
Score: 1

NDC Code Structure

  • 0220 - Boiron
    • 0220-9338 - Sinuscalm

NDC 0220-9338-04

Package Description: 60 TABLET in 1 CARTON

NDC Product Information

Sinuscalm with NDC 0220-9338 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 tablet and is administered via oral form.

Labeler Name: Boiron

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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: 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: 06-01-2019 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 Label Images

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 (0.8MG), SANGUINARIA CANADENSIS 3C HPUS (0.8 MG) ,SPIGELIA ANTHELMIA 3C HPUS (0.8 MG)**

Otc - Purpose

BELLADONNA 3C HPUS RELIEVES SINUS PAIN WITH STUFFY NOSE *

(contains less than 10 -8 mg alkaloids)
SANGUINARIA CANADENSIS 3C HPUS RELIEVES SINUS PAIN WITH RUNNY NOSE*

(contains less than 10 -8 mg alkaloids)
SPIGELIA ANTHELMIA 3C HPUS RELIEVES SINUS PAIN WITH POST NASAL DRIP*(contains less than 10 -8 mg alkaloids)

Indications & Usage

TEMPORARILY RELIEVES NASAL CONGESTION SINUS PAIN HEADACHE DUE TO THE COMMON COLD OR ALLERGIES

Otc - Ask Doctor

Ask a doctor before use in children under 6 years of age.

Otc - Stop Use

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 breast-feeding 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, allow 2 tablets to dissolve 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 glued carton end flaps are open or if the blister seal is broken.Contains 60 TabletsStore below 86° F (30° C)*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, CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE

Otc - Questions

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

BoironUSA.com Info@boiron.com

Distributed by Boiron, Inc. Newtown Square, PA 19073

* Please review the disclaimer below.

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