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TEXACLEAR PAIN RELIEVER 8 oz


SPL UNCLASSIFIED SECTION

TEXACLEARPain Reliever

(choline salicylate&caffeine), solution

GM Pharmaceuticals, Inc.

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TexaClearPain Reliever Drug Facts

Drug Facts


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

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:

Stomach bleedingwarning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • hives
  • skin reddening
  • rash
  • facial swelling
  • shock
  • asthma (wheezing)

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

  • donot 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 68-86ºF (20-30ºC)
  • 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