Formula 3 Cough Syrup

Cough Syrup

Vitality Works, Inc.
Human Otc Drug
NDC 64616-072

Formula 3 Cough Syrup also known as Cough Syrup is a human otc drug labeled by 'Vitality Works, Inc.'. National Drug Code (NDC) number for Formula 3 Cough Syrup is 64616-072. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Formula 3 Cough Syrup drug includes Pelargonium Sidoides Root - 1 [hp_X]/mL Prunus Serotina Bark - 1 [hp_X]/mL Sambucus Nigra Flower - 1 [hp_X]/mL . The currest status of Formula 3 Cough Syrup drug is Active.

Drug Information:

Drug NDC:	64616-072
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Formula 3 Cough Syrup
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Cough Syrup
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Vitality Works, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	PELARGONIUM SIDOIDES ROOT - 1 [hp_X]/mL PRUNUS SEROTINA BARK - 1 [hp_X]/mL SAMBUCUS NIGRA FLOWER - 1 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	07 Jul, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Vitality Works, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0608274109506
UPC stands for Universal Product Code.
UNII:	H6J53HEX8E 5D48E975HA 07V4DX094T
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
64616-072-01	118 mL in 1 BOTTLE (64616-072-01)	07 Jul, 2010	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Formula 3 Cough Syrup

Cough Syrup

Liquid
Vitality Works, Inc.
NDC: 64616-072

Drosera Plex

Cough Syrup

Syrup
Seroyal USA
NDC: 62106-3126

Purpose:

Formula 3 cough syrup umckaloabo - cough suppressant wild cherry bark - cough suppressant european elderberry - cough suppressant

Product Elements:

Formula 3 cough syrup cough syrup pelargonium sidoides root pelargonium sidoides root prunus serotina bark prunus serotina bark sambucus nigra flower sambucus nigra flower honey american elderberry citric acid monohydrate water alcohol potassium sorbate stevia leaf xanthan gum raspberry natural flavor mixed berry natural flavor

Indications and Usage:

Formula 3 cough syrup temprarily relieves symptoms of cough including dryness and minor throat and bronchial irritation associated with the common cold.

Warnings:

Formula 3 cough syrup do not give product for persistent or chronic cough such as occurs with asthma or if cough is accompanied excessive phlegm (mucus) unless directed by doctor. stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as a persistent cough may be a sign of a serious condition. if pregnant or breast feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Dosage and Administration:

Formula 3 cough formula - children 2 to 4 years of age: 1/2 teaspoon every 3 hours, or as needed. - children 5 to 11 years of age: 1 teaspoon every 3 hours, or as needed. children under 2 years of age: consult your healthcare practitioner

Package Label Principal Display Panel:

Formula 3 cough formula label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.