NDC 58809-389 Texaclear Pain Reliever

Caffeine, Choline Salicylate

NDC Product Code 58809-389

NDC 58809-389-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Texaclear Pain Reliever with NDC 58809-389 is a 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.

Labeler Name: Gm Pharmaceuticals, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Texaclear Pain Reliever Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHOLINE SALICYLATE 870 mg/30mL
  • CAFFEINE 65 mg/30mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)

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.

Labeler Name: Gm Pharmaceuticals, Inc
Labeler Code: 58809
FDA Application Number: part343 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 12-14-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Texaclear Pain Reliever Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients Per 30Ml

Caffeine 65 mgCholine 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○ backachetemporarily reduces fever

Warnings

  • Reye's syndromeChildren 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 alertSalicylates (NSAIDs) may cause a severe allergic reaction which may include:hivesskin reddeningrashfacial swellingshockasthma (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 olderhave had stomach ulcers or bleeding problemstake blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake 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 youyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcersyou have asthma

Ask A Doctor Or Pharmacist Before Use If

  • Under a doctor's care for any serious conditiontaking 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 coffeetake 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 bettersymptoms do not improve pain gets worse or lasts more than 10 daysringing in the ears or loss of hearing occursredness or swelling is present new symptoms occurfever 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 persistdo 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 mgread all product information before using store at room temperature 68-86ºF (20-30ºC) avoid excessive heat and humiditytamper 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

* Please review the disclaimer below.