Texaclear Pain Reliever Liquid
FDA Label NDC 58809-389

17 label sections · Submitted to the FDA by Gm Pharmaceuticals, Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Texaclear Pain Reliever (NDC 58809-389). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients per 30ml, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

* Please review the disclaimer below.