NDC 58809-389 Texaclear Pain Reliever
Caffeine, Choline Salicylate Liquid Oral

Product Information

Texaclear Pain Reliever is a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Texaclear Pain Reliever is caffeine, choline salicylate. The product's dosage form is liquid and is administered via oral form.

Product Code58809-389
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Texaclear Pain Reliever
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Caffeine, Choline Salicylate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Gm Pharmaceuticals, Inc
Labeler Code58809
FDA Application Number What is the FDA Application Number?
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.
part343
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-14-2017
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Texaclear Pain Reliever?


Product Packages

NDC 58809-389-08

Package Description: 237 mL in 1 BOTTLE

Product Details

What are Texaclear Pain Reliever Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CAFFEINE 65 mg/30mL - A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
  • CHOLINE SALICYLATE 870 mg/30mL

Texaclear Pain Reliever Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1994320 - caffeine 65 MG / choline salicylate 870 MG in 30 mL Oral Solution
  • RxCUI: 1994320 - caffeine 2.17 MG/ML / choline salicylate 29 MG/ML Oral Solution
  • RxCUI: 1994320 - caffeine 65 MG / choline salicylate 870 MG per 30 ML Oral Solution

Texaclear Pain Reliever Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Texaclear Pain Reliever Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients Per 30Ml



Caffeine 65 mg

Choline Salicylate (NSAID)* 870 mg


Purpose



Pain Reliever Aid

Pain Reliever / Fever Reducer (NSAID)

*nonsteroidal anti-inflammatory drug


Uses



  • temporarily relieves minor aches and pains due to:
    ○ headache
    ○ minor arthritis pain
    ○ muscle aches
    ○ menstrual cramps
    ○ backache
    • temporarily reduces fever

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:
    ○ feel faint
    ○ vomit blood
    ○ have bloody or black stools
    ○ 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.


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

Other Information



  • each 30mL contains: Sodium 19 mg
  • read all product information before using
  • store at room temperature 68-86°F (20-30°C)
  • avoid excessive heat and humidity
  • tamper evident: Do not use if foil seal under cap is broken or missing read all

Inactive Ingredients



anhydrous citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol


Questions Or Comments?



Call 1-888-423-0139

R071316M


Principal Display Panel



NDC 58809-389-08
TEXACLEAR
Pain
Reliever
8 fl oz (237 mL)


* Please review the disclaimer below.