NDC 0220-9060 Coldcalm Kids

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

NDC Product Code 0220-9060

NDC CODE: 0220-9060

Proprietary Name: Coldcalm Kids 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: Strychnos Nux-vomica Seed, Pulsatilla Vulgaris, Onion, Phytolacca Americana Root, Potassium Dichromate, Gelsemium Sempervirens Root, Eupatorium Perfoliatum Flowering Top, Apis Mellifera, 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

NDC 0220-9060-09

Package Description: 30 POUCH in 1 PACKAGE > 5 LIQUID in 1 POUCH

NDC Product Information

Coldcalm Kids with NDC 0220-9060 is a a human over the counter drug product labeled by Boiron. The generic name of Coldcalm Kids is strychnos nux-vomica seed, pulsatilla vulgaris, onion, phytolacca americana root, potassium dichromate, gelsemium sempervirens root, eupatorium perfoliatum flowering top, apis mellifera, . 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.

Coldcalm Kids 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.

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

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: 05-15-2018 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.

Coldcalm Kids Product Label Images

Coldcalm Kids 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 HPUS (0.125 mL)**Apis mellifica 15C HPUS (0.125 mL)**Eupatorium perfoliatum 3C HPUS (0.125 mL)**Gelsemium sempervirens 6C HPUS (0.125 mL)** (contains less than 10
-11 mg gelsemine alkaloids)
Kali bichromicum 6C HPUS (0.125 mL)** (contains less than 10
-10 mg chromium)
Nux vomica 3C HPUS (0.125 mL)** (contains less than 10
-5 strychnine alkaloids)
Phytolacca decandra 6C HPUS (0.125 mL)**Pulsatilla 6C HPUS (0.125 mL)**(in each vial)The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Allium cepa 3C HPUS (0.125 mL) ... Relieves sneezing and runny nose*Apis mellifica 15C HPUS (0.125 mL) ... Relieves nasal congestion*Eupatorium perfoliatum 3C HPUS (0.125 mL) ... Relieves body aches associated with colds*Gelsemium sempervirens 6C HPUS (0.125 mL) ...Relieves headeaches associated with colds*Kali bichromicum 6C HPUS (0.125 mL) ... Relieves nasal discharge*Nux vomica 3C HPUS (0.125 mL) ... Relieves sneezing attacks*Phytolacca decandra 6C HPUS (0.125 mL) ... Relieves mild fever*Pulsatilla 6C HPUS (0.125 mL) ... Relieves colds with a loss of taste and smell*

Indications & Usage

Temporarily relieves cold symptoms such as sneezing, runny nose, and nasal congestion.

Otc - Ask Doctor

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

Otc - Stop Use

Stop use and ask doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100°F (38°C) develops, or if symptoms persist for more than 2 days, worsen or new symptoms occur.

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

  • Children 6 months of age and older:
  • Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement.
  • Tear open the foil pouch at the notched edge.Snap off pre-measured dose.Twist to open.Squeeze entire contents into mouth.

Other

  • Do not use if glued carton end flaps are open or if inner foil pouch and vials are not intactdo not refrigerate or freezeafter opening foil pouch: store unused vials in the foil pouch for no longer than 3 months at a temperature that does not exceed 77°F (25°C)after opening the vial: the product must be used immediatelyafter administering discard vialdo not reusecontains 0.0015% alcohol30 Pre-Measured Liquid Doses.034 fl oz (1 mL) per doseNo Known Drug InteractionsMulti-Symptom Cold Relief*Cold Relief*Sneezy, Runny Nose*

Inactive Ingredient

Alcohol, purified water

Otc - Questions

ColdCalm.com

BoironUSA.com

[email protected]

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

Distributed by Boiron Inc. Newtown Square, PA 19073-3267

* Please review the disclaimer below.