Texaclear Congestion And Pain Sinus Relief

Choline Salicylate,guaifenesin, Phenylephrine Hydrochloride

Gm Pharmaceuticals, Inc
Human Otc Drug
NDC 58809-346

Texaclear Congestion And Pain Sinus Relief also known as Choline Salicylate,guaifenesin, Phenylephrine Hydrochloride is a human otc drug labeled by 'Gm Pharmaceuticals, Inc'. National Drug Code (NDC) number for Texaclear Congestion And Pain Sinus Relief is 58809-346. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Texaclear Congestion And Pain Sinus Relief drug includes Choline Salicylate - 870 mg/30mL Guaifenesin - 200 mg/30mL Phenylephrine Hydrochloride - 10 mg/30mL . The currest status of Texaclear Congestion And Pain Sinus Relief drug is Active.

Drug Information:

Drug NDC:	58809-346
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:	Texaclear Congestion And Pain Sinus Relief
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:	Choline Salicylate,guaifenesin, Phenylephrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Gm 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:	CHOLINE SALICYLATE - 870 mg/30mL GUAIFENESIN - 200 mg/30mL PHENYLEPHRINE HYDROCHLORIDE - 10 mg/30mL
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:	21 Oct, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 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, 2024
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:	GM Pharmaceuticals, INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1653155
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:	KD510K1IQW 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
58809-346-08	237 mL in 1 BOTTLE, PLASTIC (58809-346-08)	21 Oct, 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

Texaclear Congestion And Pain Sinus Relief

Choline Salicylate,guaifenesin, Phenylephrine Hydrochloride

Liquid
GM Pharmaceuticals, INC
NDC: 58809-346

Purpose:

Purpose pain reliever / fever reducer expectorant nasal decongestant

Product Elements:

Texaclear congestion and pain sinus relief choline salicylate,guaifenesin, phenylephrine hydrochloride propylene glycol water sodium citrate saccharin sodium sorbitol edetate disodium glycerin guaifenesin guaifenesin choline salicylate salicylic acid phenylephrine hydrochloride phenylephrine

Indications and Usage:

Uses temporarily relieves nasal congestion due to common cold, hay fever and other upper respiratory allergies nasal congestion minor aches and pains headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive

Warnings:

throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer. if you are now taking a prescription monoamine oxidase inhibitor (maoi)(certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs disease), or 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. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease you have a cough with excessive phlegm (mucus) you have difficulty in urination due to enlargement of the prostate gland you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema you have asthma you have a sodium restricted diet. ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning the blood) diabetes, gout, or arthritis. under a doctorâs care for any serious condition taking a diuretic. when using this product do not use more than directed stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use salicylates (nsaid) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Do Not Use:

Warnings reye âs syndrome: children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reyeâs syndrome, a rare but serious illness. allergy alert: salicylates (nsaids) may cause a severe allergic reaction which may include: hives rash shock skin reddening facial swelling asthma (wheezing) stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non-prescription nsaids (aspirin, ibuprofen naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer. if you are now taking a prescription monoamine oxidase inhibitor (maoi)(certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs disease), or 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. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease you have a cough with excessive phlegm (mucus) you have difficulty in urination due to enlargement of the prostate gland you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema you have asthma you have a sodium restricted diet. ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning the blood) diabetes, gout, or arthritis. under a doctorâs care for any serious condition taking a diuretic. when using this product do not use more than directed stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use salicylates (nsaid) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

When Using:

When using this product do not use more than directed

Dosage and Administration:

Directions do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period. use enclosed dose cup keep dosage cup with product ml= milliliter adults and children 12 years of age and over: 30 ml every 4 hours children under 12 years of age: do not use.

Stop Use:

Stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better

Package Label Principal Display Panel:

Principal display panel ndc 58809-346-08 texaclear congestion & sinus pain relief 8 fl oz(237 ml) principal display panel ndc 58809-346-08 texaclear congestion & sinus pain relief 8 fl oz(237 ml)

Further Questions:

Questions or comments? call 1-888-535-0305 9 a.m. - 5 p.m. cst distributed by: gm pharmaceuticals, inc. arlington, tx. 76015 keep leaflet after opening m-r080917

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.