NDC 55714-2258 Tobacco Withdrawal

NDC Product Code 55714-2258

NDC 55714-2258-0

Package Description: .5 mL in 1 BOTTLE, GLASS

NDC 55714-2258-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-2258-2

Package Description: 59.14 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

Tobacco Withdrawal with NDC 55714-2258 is a product labeled by Newton Laboratories, Inc.. The generic name of Tobacco Withdrawal 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: 03-01-2011 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.

Tobacco Withdrawal Product Label Images

Tobacco Withdrawal 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

Tobacco Withdrawal  Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally 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

Arsenicum alb. 15x, Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Daphne indica 15x, Ignatia 15x, Iris versicolor 15x, Lycopodium 15x, Nicotinum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Tabacum 15x, Echinacea 3x, Taraxacum 3x, Valeriana 3x.

Otc - Purpose Section

Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

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.