FDA.reportPublic FDA data

Texaclear Fast Acting Allergy Relief

Manufacturer
GM Pharmaceuticals, INC
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:41:50

Label at a glance#

ProductTexaclear Fast Acting Allergy Relief
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure10 sections

Indications and uses

■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:       ■ runny nose       ■ sneezing       ■ itching of the nose or throat       ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation

Dosage and administration

■ do not exceed 4 doses in any 24 hour period ■ use enclosed dose cup and keep with product ■ mL= milliliter ■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs ■ children under 12 years of age: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

(Chlophedianol HCI & Pyrilamine Maleate), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Chlophedianol HCl 25 mg 

Pyrilamine Maleate 50 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:

      ■ runny nose

      ■ sneezing

      ■ itching of the nose or throat

      ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

■ taking sedative or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ do not use more than directed

■ marked drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

■ new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

■ do not exceed 4 doses in any 24 hour period

■ use enclosed dose cup and keep with product

■ mL= milliliter

■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs

■ children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

■ each 30 mL contains: Sodium 17 mg

■ read all product information before using

■ store at room temperature 20-30°C (68-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-360-08
TEXACLEAR
FAST ACTING
ALLERGY
RELIEF
8 fl oz (237 mL)

Texaclear PDP
Texaclear PDP
TexaClear Drug Facts
TexaClear Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672917chlophedianol HCl 25 MG / pyrilamine maleate 50 MG in 30 mL Oral SolutionPSN12
2672917chlophedianol hydrochloride 0.833 MG/ML / pyrilamine maleate 1.67 MG/ML Oral SolutionSCD12
2672917chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 25 MG per 15 ML Oral SolutionSY12
2672917chlophedianol hydrochloride 25 MG / pyrilamine maleate 50 MG per 30 ML Oral SolutionSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809360086GTIN-13: 0358809360086
EAN-13: 0358809360086
GTIN-12: 358809360086
UPC-A: 358809360086
GTIN storage (14 digits): 00358809360086		texaclear-fast-acting-allergy-relief-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-360-08Texaclear Fast Acting Allergy Relief237 mL in 1 BOTTLE, PLASTICLIQUID23712

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998Y1
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZA1
CHLOPHEDIANOLACTIVE MOIETY42C50P12AP1
PYRILAMINEACTIVE MOIETYHPE317O9TL1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
58809-36058809-360-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-10-03full-release2026-06-01 01:15:43

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii+route
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / ORAL46 mgExact identifier — unii+route
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / ORAL46 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii+route
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii+route
44 equally ranked IID candidates

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 Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
ndc (package): 58809-360-08
ndc (product): 58809-360
ndc11 (package): 58809036008
spl id: 42b3cfc3-8903-edc1-e063-6394a90aa6fe
spl set id: 17a2f643-fa98-21ee-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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