FDA.reportPublic FDA data

TEXACLEAR PAIN RELIEVER

Manufacturer
GM Pharmaceuticals, INC
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:39:02

Label at a glance#

ProductTEXACLEAR PAIN RELIEVER
Active ingredientCHOLINE SALICYLATE, CAFFEINE
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: ○ headache ○ minor arthritis pain ○ muscle aches ○ menstrual cramps ○ backache temporarily reduces fever

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TEXACLEARPain Reliever

(choline salicylate&caffeine), solution

GM Pharmaceuticals, Inc.

--

TexaClearPain Reliever Drug Facts

Drug Facts

Active Ingredients per 30mL

OTC - ACTIVE INGREDIENT SECTION

Caffeine 65 mg

Choline Salicylate (NSAID)* 870 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever Aid

Pain Reliever / Fever Reducer ( NSAID)

*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:

    ○ headache

    ○ minor arthritis pain

    ○ muscle aches

    ○ menstrual cramps

    ○ backache
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • if you ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking a prescription drug for diabetes, gout, or arthritis.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

SPL UNCLASSIFIED SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

R071316M

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-389-08

TEXACLEAR

Pain

Reliever

8 fl oz (237 mL)

principaldisplaylabelprincipaldisplaylabel

Onsert2Onsert2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1994320caffeine 65 MG / choline salicylate 870 MG in 30 mL Oral SolutionPSN10
1994320caffeine 2.17 MG/ML / choline salicylate 29 MG/ML Oral SolutionSCD10
1994320caffeine 65 MG / choline salicylate 870 MG per 30 ML Oral SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809389087GTIN-13: 0358809389087
EAN-13: 0358809389087
GTIN-12: 358809389087
UPC-A: 358809389087
GTIN storage (14 digits): 00358809389087		Principaldisplaylabel.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-389-08TEXACLEAR PAIN RELIEVER237 mL in 1 BOTTLELIQUID23710

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-38958809-389-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
CHOLINE SALICYLATEKD510K1IQWACTIB
CAFFEINE3G6A5W338EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-10-07full-release2026-06-01 00:22:50

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEXACLEAR PAIN RELIEVERCAFFEINE, CHOLINE SALICYLATEGM Pharmaceuticals, INC065bd10c-3bcf-486f-a49c-40544127007f2025-10-15WarningsExact identifier
ndc (package): 58809-389-08
ndc (product): 58809-389
ndc11 (package): 58809038908
spl id: 4139160a-f694-24ee-e063-6294a90a1f52
spl set id: 065bd10c-3bcf-486f-a49c-40544127007f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.