TEXACLEAR FAST ACTING ALLERGY RELIEF

Manufacturer
GM Pharmaceuticals, Inc.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:16

Label at a glance#

ProductTEXACLEAR FAST ACTING ALLERGY RELIEF
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure17 sections

Storage and handling

Other information Each 57 mL bottle contains: Sodium 33 mg. tamper evident: Do not use if foil seal under cap is broken or missing. read all product information before using Store at 68° to 86°F (20° to 30°C). this package is child resistant

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 57 mL)

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

Uses

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

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

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days, tends 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not exceed 4 (57mL) bottles in a 24-hour period

Adults and children

12 years of age

and over:

Take 1 (57mL) bottle every 6 to 8 hours

Children under

12 years of age:

Do not use.

STORAGE AND HANDLING SECTION

Other information

  • Each 57 mL bottle contains: Sodium 33 mg.
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • Store at 68° to 86°F (20° to 30°C).
  • this package is child resistant

INACTIVE INGREDIENT SECTION

Inactive ingredients

Anhydrous Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

OTC - QUESTIONS SECTION

Questions? Comments?

Call 1-888-535-0305

SPL UNCLASSIFIED SECTION

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

PRODUCT LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image1image1image2image2image3image3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58809-063-602024-01-30C16284748780-11030e365-66fd-111a-e063-dadaa90a10e2TEXACLEAR ONE DOSE ALLERGY RELIEF

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
58809-06358809-063-60

Ingredients#

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

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

Source Document#

Source XML

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
1c5a3d43-9741-d9ad-e063-6394a90adc0fd0daa5d4-cb1c-2ab4-e053-2a95a90a57952024-07-03WarningsExact identifier
spl set id: d0daa5d4-cb1c-2ab4-e053-2a95a90a5795

Reported adverse events (FAERS/openFDA)#

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