TEXACLEAR PAIN RELIEVER- caffeine, choline salicylate liquid

TEXACLEAR PAIN RELIEVER by

Drug Labeling and Warnings

TEXACLEAR PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TEXACLEAR Pain Reliever 

(choline salicylate & caffeine), solution

GM Pharmaceuticals, Inc.

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TexaClear Pain 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 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 68-86ºF (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)

INGREDIENTS AND APPEARANCE

TEXACLEAR PAIN RELIEVER 
caffeine, choline salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-389
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ)	CHOLINE SALICYLATE	870 mg  in 30 mL
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-389-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/14/2017

Labeler - GM Pharmaceuticals, INC (793000860)