Sucrets

Dyclonine Hcl, Menthol, And Pectin

Insight Pharmaceuticals Llc
Human Otc Drug
NDC 63736-567

Sucrets also known as Dyclonine Hcl, Menthol, And Pectin is a human otc drug labeled by 'Insight Pharmaceuticals Llc'. National Drug Code (NDC) number for Sucrets is 63736-567. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Sucrets drug includes Dyclonine Hydrochloride - 2 mg/1 Menthol - 5 mg/1 Pectin - 6 1/1 . The currest status of Sucrets drug is Active.

Drug Information:

Drug NDC:	63736-567
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:	Sucrets
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:	Dyclonine Hcl, Menthol, And Pectin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Insight Pharmaceuticals Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Lozenge
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:	DYCLONINE HYDROCHLORIDE - 2 mg/1 MENTHOL - 5 mg/1 PECTIN - 6 1/1
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:	OTC MONOGRAPH NOT FINAL
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:	04 Nov, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 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.
Application Number:	part356
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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:	Insight Pharmaceuticals LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1992531
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	ZEC193879Q L7T10EIP3A 89NA02M4RX
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
63736-567-18	18 LOZENGE in 1 CAN (63736-567-18)	04 Nov, 2014	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

Sucrets

Dyclonine Hcl, Menthol, And Pectin

Lozenge
Insight Pharmaceuticals LLC
NDC: 63736-567

Purpose:

Active ingredients (per lozenge) purpose dyclonine hydrochloride, 2 mg oral anesthetic/analgesic menthol, 5 mg cough suppressant pectin, 6 mg demulcent

Product Elements:

Sucrets dyclonine hcl, menthol, and pectin dyclonine hydrochloride dyclonine menthol menthol pectin pectin corn syrup fd&c yellow no. 5 fd&c yellow no. 6 honey lemon oil propylene glycol sucrose tartaric acid water (honey lemon)

Indications and Usage:

Uses temporarily relieves: occasional minor irritation, pain, sore throat, and sore mouth cough associated with a cold or inhaled irritants for protection of irritated areas in sore mouth and throat

Warnings:

Warnings sore through warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma or emphysema cough that occurs with too mych phlegm (mucus) stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash, or fever develops cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. these could be signs 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 (1-800-222-1222) right away.

Dosage and Administration:

Directions do not use more than directed adults and children 4 years of age and older: dissolve 1 lozenge slowly in the mouth. may be repeated every 2 hours as needed or as directed by a doctor or dentist children under 4 years of age: consult a doctor or dentist

Stop Use:

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash, or fever develops cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel sucrets sore throat, cough & dry mouth dyclonine/oral anesthetic menthol/cough suppressant pectin/dry mouth 18 lozenges sucrets sore throat, cough & sore throat 18 ct tin

Further Questions:

Questions 1-800-344-7239 sucrets.com

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.