Label: TEXACLEAR PAIN RELIEVER- caffeine, choline salicylate liquid

  • NDC Code(s): 58809-389-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 22, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    TEXACLEARPain Reliever

    (choline salicylate&caffeine), solution

    GM Pharmaceuticals, Inc.

    --

    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)

    principaldisplaylabel

    Onsert2

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR PAIN RELIEVER 
    caffeine, choline salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-389
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-389-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/14/2017
    Labeler - GM Pharmaceuticals, INC (793000860)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sovereign Pharmaceuticals, LLC623168267manufacture(58809-389)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!