Mucinex Instasoothe Sore Throat Plus Cough Relief

Dextromethorphan Hydrobromide And Hexylresorcinol

Rb Health (us) Llc
Human Otc Drug
NDC 72854-263

Mucinex Instasoothe Sore Throat Plus Cough Relief also known as Dextromethorphan Hydrobromide And Hexylresorcinol is a human otc drug labeled by 'Rb Health (us) Llc'. National Drug Code (NDC) number for Mucinex Instasoothe Sore Throat Plus Cough Relief is 72854-263. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Mucinex Instasoothe Sore Throat Plus Cough Relief drug includes Dextromethorphan Hydrobromide - 5 mg/1 Hexylresorcinol - 2 mg/1 . The currest status of Mucinex Instasoothe Sore Throat Plus Cough Relief drug is Active.

Drug Information:

Drug NDC:	72854-263
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:	Mucinex Instasoothe Sore Throat Plus Cough Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Mucinex Instasoothe
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	SORE THROAT PLUS COUGH RELIEF
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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:	Dextromethorphan Hydrobromide And Hexylresorcinol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Rb Health (us) 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:	DEXTROMETHORPHAN HYDROBROMIDE - 5 mg/1 HEXYLRESORCINOL - 2 mg/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:	01 Jul, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	06 May, 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:	RB Health (US) LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2566823
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:	9D2RTI9KYH R9QTB5E82N
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.
Pharmacologic Class:	Sigma-1 Agonist [EPC] Sigma-1 Receptor Agonists [MoA] Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] Uncompetitive NMDA Receptor Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
72854-263-20	20 POUCH in 1 BAG (72854-263-20) / 1 LOZENGE in 1 POUCH	01 Jul, 2021	N/A	No
72854-263-40	40 POUCH in 1 BAG (72854-263-40) / 1 LOZENGE in 1 POUCH	01 Jul, 2021	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

Mucinex Instasoothe Sore Throat Plus Cough Relief

Dextromethorphan Hydrobromide And Hexylresorcinol

Lozenge
RB Health (US) LLC
NDC: 72854-263

Purpose:

Active ingredients (in each lozenge) purposes dextromethorphan hbr 5.0 mg cough suppressant hexylresorcinol 2.0 mg oral pain reliever

Product Elements:

Mucinex instasoothe sore throat plus cough relief dextromethorphan hydrobromide and hexylresorcinol dextromethorphan hydrobromide dextromethorphan hexylresorcinol hexylresorcinol corn syrup d&c yellow no. 10 ethyl lactate fd&c blue no. 1 propylene glycol sucrose water s

Indications and Usage:

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold occasional irritation and pain due to a sore mouth or sore throat pain associated with canker sores

Warnings:

Warnings sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. in children under 6 years of age when using this product do not exceed recommended dosage ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fev Read more...

er, rash, 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 right away.

Do Not Use:

When Using:

When using this product do not exceed recommended dosage

Dosage and Administration:

Directions dose as follows or as directed by a doctor or dentist adults and children 12 years of age and older take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in any 24-hour period children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in any 24-hour period children under 6 years of age do not use

Stop Use:

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

Package Label Principal Display Panel:

Principal display panel - 20 drop pouch bag ndc 72854-263-20 mucinexÂ® instasootheâ¢ sore throat + cough relief dextromethorphan hbr 5.0 mg | cough suppressant hexylresorcinol 2.0 mg | oral pain reliever 3 in 1 formula â quiets cough â cooling comfort â fast acting see back panel for actual size alpine herbs & fresh mint flavor 20 medicated drops principal display panel - 20 drop pouch bag

Further Questions:

Questions? 1-866-mucinex (1-866-682-4639) you may also report side effects to this phone number.

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.