Cepacol Extra Strength Sore Throat And Cough

Benzocaine And Dextromethorphan Hydrobromide

Rb Health (us) Llc
Human Otc Drug
NDC 63824-744

Cepacol Extra Strength Sore Throat And Cough also known as Benzocaine And Dextromethorphan Hydrobromide is a human otc drug labeled by 'Rb Health (us) Llc'. National Drug Code (NDC) number for Cepacol Extra Strength Sore Throat And Cough is 63824-744. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Cepacol Extra Strength Sore Throat And Cough drug includes Benzocaine - 7.5 mg/1 Dextromethorphan Hydrobromide - 5 mg/1 . The currest status of Cepacol Extra Strength Sore Throat And Cough drug is Active.

Drug Information:

Drug NDC:	63824-744
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:	Cepacol Extra Strength Sore Throat And Cough
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Cepacol
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Extra Strength Sore Throat and Cough
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:	Benzocaine And Dextromethorphan Hydrobromide
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:	BENZOCAINE - 7.5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE - 5 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:	05 May, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 Jan, 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.
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:	1039251 1039255
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.
NUI:	N0000185508 N0000175629 N0000184306 M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	U3RSY48JW5 9D2RTI9KYH
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 EPC:	Standardized Chemical Allergen [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Sigma-1 Agonist [EPC] Sigma-1 Receptor Agonists [MoA] Standardized Chemical Allergen [EPC] 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
63824-744-16	2 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK	05 May, 2014	N/A	No
63824-744-36	3 BLISTER PACK in 1 CARTON (63824-744-36) / 12 LOZENGE in 1 BLISTER PACK	01 May, 2019	N/A	No
63824-744-94	1 BLISTER PACK in 1 CARTON (63824-744-94) / 4 LOZENGE in 1 BLISTER PACK	05 May, 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

Cepacol Extra Strength Sore Throat And Cough

Benzocaine And Dextromethorphan Hydrobromide

Lozenge
RB Health (US) LLC
NDC: 63824-744

Purpose:

Active ingredients (in each lozenge) purposes benzocaine 7.5 mg oral pain reliever dextromethorphan hbr 5 mg cough suppressant

Product Elements:

Cepacol extra strength sore throat and cough benzocaine and dextromethorphan hydrobromide benzocaine benzocaine dextromethorphan hydrobromide dextromethorphan fd&c blue no. 1 fd&c red no. 40 isomalt maltitol propylene glycol water sodium bicarbonate sucralose s

Indications and Usage:

Uses for the temporary relief of occasional cough due to minor throat and bronchial irritation as may occur with the common cold sore throat sore mouth minor irritation pain pain associated with canker sores

Warnings:

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. for teething in children under 6 years of age 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 fever, 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 exceed recommended dosage.

Do Not Use:

Warnings methemoglobinemia warning use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics. 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. for teething in children under 6 years of age 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 fever, 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 exceed recommended dosage.

Dosage and Administration:

Directions 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 24 hours, or as directed by a doctor or dentist 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 24 hours, or as directed by a doctor or dentist 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 - 16 lozenge blister pack carton ndc 63824-744-16 read all warnings c?pacol ® extra strength #1 doctor recommended sore throat & cough benzocaine 7.5 mg oral pain reliever | dextromethorphan hbr 5 mg cough suppressant relieves sore throat pain quiets cough fast acting maximum numbing* 16 lozenges mixed berry *based on amount of benzocaine per adult dose principal display panel - 16 lozenge blister pack carton

Further Questions:

Questions? 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.