Texaclear Pain Reliever Liquid
FDA Label NDC 58809-389

Full FDA labeling including 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 active ingredients per 30ml, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.