Quitters Relief Irritability

Aconitum Napellus Whole, Anamirta Cocculus Seed, Arsenic Trioxide, Delphinium Staphisagria Seed, Dibasic Potassium Phosphate, Gelsemium Sempervirens Root, Phosphorus, Silver Nitrate And Sulfur

Hyland's Inc.
Human Otc Drug
NDC 54973-4007

Quitters Relief Irritability also known as Aconitum Napellus Whole, Anamirta Cocculus Seed, Arsenic Trioxide, Delphinium Staphisagria Seed, Dibasic Potassium Phosphate, Gelsemium Sempervirens Root, Phosphorus, Silver Nitrate And Sulfur is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Quitters Relief Irritability is 54973-4007. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Quitters Relief Irritability drug includes Aconitum Napellus Whole - 30 [hp_X]/1 Anamirta Cocculus Seed - 30 [hp_X]/1 Arsenic Trioxide - 30 [hp_X]/1 Delphinium Staphisagria Seed - 12 [hp_X]/1 Dibasic Potassium Phosphate - 12 [hp_X]/1 Gelsemium Sempervirens Root - 30 [hp_X]/1 Phosphorus - 30 [hp_X]/1 Silver Nitrate - 30 [hp_X]/1 Strychnos Ignatii Seed - 30 [hp_X]/1 Sulfur - 30 [hp_X]/1 . The currest status of Quitters Relief Irritability drug is Active.

Drug Information:

Drug NDC:	54973-4007
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:	Quitters Relief Irritability
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:	Aconitum Napellus Whole, Anamirta Cocculus Seed, Arsenic Trioxide, Delphinium Staphisagria Seed, Dibasic Potassium Phosphate, Gelsemium Sempervirens Root, Phosphorus, Silver Nitrate And Sulfur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	ACONITUM NAPELLUS WHOLE - 30 [hp_X]/1 ANAMIRTA COCCULUS SEED - 30 [hp_X]/1 ARSENIC TRIOXIDE - 30 [hp_X]/1 DELPHINIUM STAPHISAGRIA SEED - 12 [hp_X]/1 DIBASIC POTASSIUM PHOSPHATE - 12 [hp_X]/1 GELSEMIUM SEMPERVIRENS ROOT - 30 [hp_X]/1 PHOSPHORUS - 30 [hp_X]/1 SILVER NITRATE - 30 [hp_X]/1 STRYCHNOS IGNATII SEED - 30 [hp_X]/1 SULFUR - 30 [hp_X]/1
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:	15 Dec, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Jun, 2026
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:	Hyland's 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.
UNII:	U0NQ8555JD 810258W28U S7V92P67HO 00543AP1JV CI71S98N1Z 639KR60Q1Q 27YLU75U4W 95IT3W8JZE 1NM3M2487K 70FD1KFU70
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
54973-4007-1	1 BOTTLE in 1 CARTON (54973-4007-1) / 100 TABLET in 1 BOTTLE	15 Dec, 2020	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

Quitters Relief Irritability

Aconitum Napellus Whole & more..

Tablet
Hyland's Inc.
NDC: 54973-4007

Purpose:

Temporarily relieves symptoms of irritability associated with smoking cessation, including: anxiousness, restlessness, nervous, tension, occasional sleeplessness

Product Elements:

Quitters relief irritability aconitum napellus whole, anamirta cocculus seed, arsenic trioxide, delphinium staphisagria seed, dibasic potassium phosphate, gelsemium sempervirens root, phosphorus, silver nitrate and sulfur lactose monohydrate anhydrous lactose acacia silver nitrate silver cation sulfur sulfur aconitum napellus whole aconitum napellus whole arsenic trioxide arsenic cation (3+) anamirta cocculus seed anamirta cocculus seed dibasic potassium phosphate phosphate ion gelsemium sempervirens root gelsemium sempervirens root strychnos ignatii seed strychnos ignatii seed delphinium staphisagria seed delphinium staphisagria seed phosphorus phosphorus off white

Indications and Usage:

Uses â temporarily relieves symptoms of irritability associated with smoking cessation, including: â anxiousness â restlessness â nervous tension â occasional sleeplessness

Warnings:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. do not use more than directed. consult a physician if symptoms persist for more than 7 days or worsen. keep this and all medications out of the reach of children. in case of emergency or accidental overdose, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Do Not Use:

Dosage and Administration:

Directions adults ages 18 years and over dissolve 2 tablets under tongue every 15 minutes up to 4 doses, then every 4 hours until relieved.

Overdosage:

In case of emergency or accidental overdose, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Package Label Principal Display Panel:

Package label - principal display panel homeopathic ndc 54973-4007-1 since 1903 hyland's quitterâs relief irritability* gentle relief for smoking cessation symptoms irritability, anxiousness, restlessness, nervous tension, occasional sleeplessness 100 quick-dissolving tablets natural relief *see note on back panel below drug facts carton

Further Questions:

Questions or comments? (800) 624-9659

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.