TEXACLEAR PAIN RELIEVER- caffeine, choline salicylate liquid
GM Pharmaceuticals, INC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
- 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 bleedingwarning
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
-
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
Questions or comments?
Call 1-888-423-0139
R071316M
PRINCIPAL DISPLAY PANEL
NDC 58809-389-08
TEXACLEAR
Pain
Reliever
8 fl oz (237 mL)