NDC 0220-9048 Coldcalm

Onion, Apis Mellifera, Atropa Belladonna, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Strychnos Nux-vomica Seed, Phytolacca Americana Root, Pulsatilla Vulgaris, Dichromate Ion

NDC Product Code 0220-9048

NDC CODE: 0220-9048

Proprietary Name: Coldcalm 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: Onion, Apis Mellifera, Atropa Belladonna, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Strychnos Nux-vomica Seed, Phytolacca Americana Root, Pulsatilla Vulgaris, Dichromate Ion 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):
;
Score: 1

NDC Code Structure

NDC 0220-9048-04

Package Description: 60 TABLET in 1 BLISTER PACK

NDC 0220-9048-29

Package Description: 120 TABLET in 1 BLISTER PACK

NDC Product Information

Coldcalm with NDC 0220-9048 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Coldcalm is onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris, dichromate ion. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Laboratoires 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.

Coldcalm 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.

  • ONION 3 [hp_C]/1
  • APIS MELLIFERA 6 [hp_C]/1
  • ATROPA BELLADONNA 6 [hp_C]/1
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 3 [hp_C]/1
  • GELSEMIUM SEMPERVIRENS ROOT 6 [hp_C]/1
  • DICHROMATE ION 6 [hp_C]/1
  • STRYCHNOS NUX-VOMICA SEED 3 [hp_C]/1
  • PHYTOLACCA AMERICANA ROOT 6 [hp_C]/1
  • PULSATILLA VULGARIS 6 [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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • LACTOSE (UNII: J2B2A4N98G)
  • 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: Laboratoires 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: 01-01-1995 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.

Coldcalm Product Label Images

Coldcalm 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

Allium cepa 3C, Apis mellifica 6C, Belladonna 6C, Eupatorium perfoliatum 3C, Gelsemium sempervirens 6C, Kali bichromicum 6C, Nux vomica 3C, Phytolacca decandra 6C, Pulsatilla 6C

Indications & Usage

Temporary relieves cold symptoms such as sneezing, runny nose, sinus and nasal congestion, and minor sore throat.

Otc - Do Not Use

Do not use if blister seal is broken.

Dosage & Administration

Directions (adults and children 3 year of age and older)At the onset of symptoms, take 1 dose (2 tablets) every 15 minutes for 2 hours. Then, take 1 dose every hour until symptoms are relieved.Allow the tablets to dissolve in the mouth.

Inactive Ingredient

Croscarmellose sodium, lactose, magnesium stearate

How Supplied

60 tablets

Otc - Purpose

Allium cepa 3C HPUS   Relieves sneezing and runny nose


Apis mellifica 6C Relieves nasal congestion


Belladonna 6C HPUS* Relieves colds with sudden onset


Eupatorium perfoliatum 3C HPUS  Relieves sinus painGelsemium sempervirens 6C HPUS  Relieves headeaches associated with colds


Kali bichromicum 6C HPUS  Relieves nasal discharge


Nux vomica 3C HPUS* Relieves sneezing attacksPhytolacca decandra 6C HPUS  Relieves sore throat associated with colds


Pulsatilla 6C HPUS Relieves colds with a loss of taste and smell* contains less than 10


-6 mg alkloids

Storage And Handling

Store at 68-77


o F

Otc - Questions

Questions, Comments



www.boironusa.com



info@boironusa.com
1-800-BOIRON-1



(1-800-264-7661)



Boiron Information Center



6 campus boulevard



Newtown Square, PA



19073-3267

Otc - Ask Doctor

Ask doctor before use in children younger than 3 years of age.

Otc - Stop Use

Stop use and ask a doctor if- Symptoms persists for more than 7 days or worsen- sore throat persists for more than 2 days, or occurs with fever, headache, rash, nausea or vomiting.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - When Using

N/A

Drug Interactions

Non-drowsy, no drug interactions.

* Please review the disclaimer below.