FDA.reportPublic FDA data

TexaClear Kids Allergy

Manufacturer
GM Pharmaceuticals, Inc.
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:39:07

Label at a glance#

ProductTexaClear Kids Allergy
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure14 sections

Indications and uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: itchy nose or throat sneezing itchy, watery eyes runny nose cough due to minor throat and bronchial irritation

Dosage and administration

Do not exceed 4 doses per 24-hours. Use enclosed dose cup and keep with product. mL = mililiter Adults and children 12 years of age and over: 60 mL (2 dose cups) every 6 to 8 hours Children 6 to under 12 years of age: 30 mL (1 dose cup) every 6 to 8 hours Children under 6 years of age: Do not use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 30 mL (2 TBSP))

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 25 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
  • runny nose
  • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Ask doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • glaucoma
  • difficulty in urination due to the enlargment of the prostate gland
  • cough that occurs with too much phlegm(mucus)
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist 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 drowsiniess may occur
  • alcohol, secatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especiially 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 persisten headace. A persisten cough may be a sign of a serious condition.
  • new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,as 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 per 24-hours.
  • Use enclosed dose cup and keep with product.
  • mL = mililiter
Adults and children 12 years of age and over:60 mL (2 dose cups) every 6 to 8 hours
Children 6 to under 12 years of age:30 mL (1 dose cup) every 6 to 8 hours
Children under 6 years of age:Do not use.

Other Information

OTHER SAFETY INFORMATION

  • each 30 mL contains: Sodium 14 mg
  • read all product information before using
  • store at room temperature 68-86°F (20-30°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76018

KEEP LEAFLET AFTER OPENING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TexaClear® Kids Allergy + Cough
NDC 58809-925-08
8 fl. oz. (237 mL)

Chlophedianol HCl – Cough Suppressant
Pyrilamine Maleate – Antihistamine

Tamper evident: do not use if foil seal under cap is broken on missing

  • Gluten Free
  • Dye Free
  • Sugar Free
  • Alcohol Free
  • Acetaminophen Free

Ages 6+
Dose every 6 to 8 hours

  • Sneezing
  • Runny Nose
  • Watery Eyes
  • Itchy Nose & Throat
  • Cough

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76018

PDPPDP

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1808189chlophedianol HCl 12.5 MG / pyrilamine maleate 25 MG in 30 mL Oral SolutionPSN9
1808189chlophedianol hydrochloride 0.417 MG/ML / pyrilamine maleate 0.833 MG/ML Oral SolutionSCD9
1808189chlophedianol HCl 12.5 MG / pyrilamine maleate 25 MG per 30 ML Oral SolutionSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358809925087GTIN-13: 0358809925087
EAN-13: 0358809925087
GTIN-12: 358809925087
UPC-A: 358809925087
GTIN storage (14 digits): 00358809925087		figure-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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-925-08TexaClear Kids Allergy237 mL in 1 BOTTLELIQUID2379

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-92558809-925-08

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
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-10-07full-release2026-06-01 00:23:03

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 Kids AllergyCHLOPHEDIANOL HCL PYRILAMINE MALEATEGM Pharmaceuticals, Inc.3b8a686f-d8e8-56db-e054-00144ff8d46c2025-10-15WarningsExact identifier
ndc (package): 58809-925-08
ndc (product): 58809-925
ndc11 (package): 58809092508
spl id: 413912d6-8c4d-3486-e063-6294a90a00bb
spl set id: 3b8a686f-d8e8-56db-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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