NDC 63083-2109 Cold And Flu Formula 2109
Liquid Oral

Product Information

What is NDC 63083-2109?

The NDC code 63083-2109 is assigned by the FDA to the product Cold And Flu Formula 2109 which is a human over the counter drug product labeled by Professional Complementary Health Formulas. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 63083-2109-2 59 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63083-2109
Proprietary Name 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.
Cold And Flu Formula 2109
Non-Proprietary Name 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.
Cold And Flu Formula
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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Professional Complementary Health Formulas
Labeler Code63083
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-15-1984
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Cold And Flu Formula 2109?


Product Packages

NDC Code 63083-2109-2

Package Description: 59 mL in 1 BOTTLE, DROPPER

Product Details

What are Cold And Flu Formula 2109 Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Cold And Flu Formula 2109 Active Ingredients UNII Codes

Cold And Flu Formula 2109 Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

* Please review the disclaimer below.

Cold And Flu Formula 2109 Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



Gan-Jiang 2X
Bo-He 3X
Jin-Yin-Hua 3X
Jing-Jie 3X
Lian-Jiao 3X
Niu-Bang-Zi 3X
Huang-Qi 6X
Zi-He-Che 6X


Questions



Professional Formulas

PO Box 2034 Lake Oswego, OR 97035


Indications



For the temporary relief of cough, shortness of breath, congestion, low-grade fever, sore throat, or weakness.*


Otc - Purpose



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings



Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a healthcare professional before use.


Directions



Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.


Other Information



Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.


Inactive Ingredients



20% ethanol, purified water.


Label



Est 1985

Professional Formulas

Complementary Health

Cold and Flu Formula

Homeopathic Remedy

2 FL. OZ. (59 mL)


* Please review the disclaimer below.