Texaclear Pain Reliever
Caffeine, Choline Salicylate
Gm Pharmaceuticals, Inc
Human Otc Drug
NDC 58809-389Texaclear Pain Reliever also known as Caffeine, Choline Salicylate is a human otc drug labeled by 'Gm Pharmaceuticals, Inc'. National Drug Code (NDC) number for Texaclear Pain Reliever is 58809-389. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Texaclear Pain Reliever drug includes Caffeine - 65 mg/30mL Choline Salicylate - 870 mg/30mL . The currest status of Texaclear Pain Reliever drug is Active.
Drug Information:
| Drug NDC: | 58809-389 |
| 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 Pain Reliever |
| 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: | Caffeine, Choline Salicylate |
| 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: | CAFFEINE - 65 mg/30mL
CHOLINE SALICYLATE - 870 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 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: | 14 Dec, 2017 |
| 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: | part343 |
| 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: | GM Pharmaceuticals, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1994320
|
| 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. |
| UPC: | 0358809389087
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175739
N0000175729
N0000175790
M0023046
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 3G6A5W338E
KD510K1IQW
|
| 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: | Central Nervous System Stimulant [EPC]
Methylxanthine [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: | Central Nervous System Stimulation [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: | Xanthines [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: | Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Methylxanthine [EPC]
Xanthines [CS]
|
| 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 |
|---|
| 58809-389-08 | 237 mL in 1 BOTTLE (58809-389-08) | 14 Dec, 2017 | 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. |
Purpose:
Purpose pain reliever aid pain reliever / fever reducer ( nsaid) *nonsteroidal anti-inflammatory drug
Product Elements:
Texaclear pain reliever caffeine, choline salicylate anhydrous citric acid glycerin propylene glycol water sodium benzoate sodium citrate saccharin sodium sorbitol choline salicylate salicylic acid caffeine caffeine
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: â headache â minor arthritis pain â muscle aches â menstrual cramps â backache temporarily reduces fever
Warnings:
Warnings reye's 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 reye's syndrome, a rare but serious illness. allergy alert salicylates (nsaids) may cause a severe allergic reaction which may include: hives skin reddening rash facial swelling shock 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 blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription 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 do not use if you ever had an allergic reacti
Read more...on to salicylates (including aspirin) or any other pain reliever/ fever reducer. ask a doctor before use if stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers you have asthma ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking a prescription drug for diabetes, gout, or arthritis. when using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat the recommended dose of this product contains about as much caffeine as a cup of coffee take with food or milk if stomach upset occurs stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better symptoms do not improve pain gets worse or lasts more than 10 days ringing in the ears or loss of hearing occurs redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use salicylates (nsaids) 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's 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 reye's syndrome, a rare but serious illness. allergy alert salicylates (nsaids) may cause a severe allergic reaction which may include: hives skin reddening rash facial swelling shock 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 blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription 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 do not use if you ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer. ask a doctor before use if stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers you have asthma ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking a prescription drug for diabetes, gout, or arthritis. when using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat the recommended dose of this product contains about as much caffeine as a cup of coffee take with food or milk if stomach upset occurs stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better symptoms do not improve pain gets worse or lasts more than 10 days ringing in the ears or loss of hearing occurs redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use salicylates (nsaids) 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 limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat the recommended dose of this product contains about as much caffeine as a cup of coffee take with food or milk if stomach upset occurs
Dosage and Administration:
Directions do not take more than directed. adults and children 12 years of age and over: take 30ml every 6 hours, while symptoms persist do not take exceed 4 doses in any 24 hours unless directed by a doctor children under 12 years of age: ask a doctor use enclosed dose cup
Stop Use:
Stop use and ask a doctor if an allergic reaction occurs. seek medical help right away. you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better symptoms do not improve pain gets worse or lasts more than 10 days ringing in the ears or loss of hearing occurs redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days
Package Label Principal Display Panel:
Principal display panel ndc 58809-389-08 texaclear pain reliever 8 fl oz (237 ml) principaldisplaylabel onsert2 onsert1
Further Questions:
Questions or comments? call 1-888-423-0139 r071316m