Ed Bron Gp

Guaifenesin And Phenylephrine

Edwards Pharmaceuticals, Inc.
Human Otc Drug
NDC 0485-0208

Ed Bron Gp also known as Guaifenesin And Phenylephrine is a human otc drug labeled by 'Edwards Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Ed Bron Gp is 0485-0208. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ed Bron Gp drug includes Guaifenesin - 100 mg/5mL Phenylephrine Hydrochloride - 5 mg/5mL . The currest status of Ed Bron Gp drug is Active.

Drug Information:

Drug NDC:	0485-0208
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:	Ed Bron Gp
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:	Guaifenesin And Phenylephrine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Edwards Pharmaceuticals, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
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:	GUAIFENESIN - 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE - 5 mg/5mL
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 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 Jun, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 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:	part341
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:	EDWARDS PHARMACEUTICALS, INC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1358627
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:	N0000193956 N0000008867 N0000009560
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	495W7451VQ 04JA59TNSJ
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:	Expectorant [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:	Decreased Respiratory Secretion Viscosity [PE] Increased Respiratory Secretions [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:	Adrenergic alpha1-Agonists [MoA] Decreased Respiratory Secretion Viscosity [PE] Expectorant [EPC] Increased Respiratory Secretions [PE] alpha-1 Adrenergic Agonist [EPC]
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
0485-0208-16	473 mL in 1 BOTTLE, PLASTIC (0485-0208-16)	01 Jun, 2012	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

Ed Bron Gp

Guaifenesin And Phenylephrine

Liquid
EDWARDS PHARMACEUTICALS, INC.
NDC: 0485-0208

Purpose:

Active ingredients (in each 5 ml teaspoonful) purpose guaifenesin 100 mg expectorant phenylephrine hcl 5 mg nasal decongestant

Product Elements:

Ed bron gp guaifenesin and phenylephrine citric acid monohydrate methylparaben propylparaben propylene glycol water sodium citrate sucralose glycerin guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine

Indications and Usage:

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings:

Warnings do not exceed recommended dosage. do not use this product 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. do not take this product, unless directed by a doctor, if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland do not take this product for persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more Read more...

than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. these could be signs of a serious condition. new symptoms occur if pregnant or breastfeeding , ask a health professional before use. keep out of reach of children. in case of accidental overdose, seek professional help or contact a poison control center immediately.

Do Not Use:

Dosage and Administration:

Directions do not exceed recommended dosage. adults and children 12 years of age and over: 2 teaspoonfuls (10 ml) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. children 6 to under 12 years of age: 1 teaspoonful (5 ml) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. children under 6 years of age: consult a doctor.

Stop Use:

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. these could be signs of a serious condition. new symptoms occur

Package Label Principal Display Panel:

Principal display panel - 473 ml bottle label ed bron gp liquid e ndc 0485-0208-16 ed bron gp liquid expectorant â¢ nasal decongestant sugar free â¢ alcohol free â¢ dye free each teaspoonful (5 ml) for oral administration contains: guaifenesin 100 mg phenylephrine hcl 5 mg orange flavor tamper evident by foil seal under cap. do not use if foil seal is broken or missing. manufactured for: edwards pharmaceuticals, inc. ripley, ms 38663 16oz. (473 ml) principal display panel - 473 ml bottle label

Further Questions:

Question? comments? call 1-800-543-9560

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.