NDC 55714-8007 Cold - Sinus

NDC Product Code 55714-8007

NDC 55714-8007-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Cold - Sinus with NDC 55714-8007 is a product labeled by Newton Laboratories, Inc.. The generic name of Cold - Sinus is . The product's dosage form is and is administered via form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: -

Product Type: 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.

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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
Start Marketing Date: 04-15-2014 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: 12-31-2019 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: I 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.

Cold - Sinus Product Label Images

Cold - Sinus 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

Indications & Usage Section

Cold - Sinus  Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Dosage & Administration Section

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Influenzinum 30x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x.

Otc - Purpose Section

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Questions Section

Www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children

* Please review the disclaimer below.