TexaClear Kids Daytime Cough and Chest Congestion

Manufacturer
GM Pharmaceuticals, INC
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:50

Label at a glance#

ProductTexaClear Kids Daytime Cough and Chest Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: the intensity of coughing cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Dosage and administration

do not exceed 6 doses per 24-hour period. measure only with the dosing cup provided. mL= milliliter Age Dose children 6 years to under 12 years 30 mL (2 dose cups) every 4 hours children 4 years to under 6 years 15 mL (1 dose cup) every 4 hours children under 4 years do not use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TexaClear Kids Daytime Cough and Chest Congestion

(dextromethorphan HBr, guaifenesin), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • temporarily relieves:
    • the intensity of coughing
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use

OTC - DO NOT USE SECTION

in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, pschiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with asthma
  • a cough that occurs with too much phlegm (mucus)
  • a sodium-restricted diet

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 6 doses per 24-hour period.
  • measure only with the dosing cup provided.
  • mL= milliliter
AgeDose
children 6 years to under 12 years30 mL (2 dose cups) every 4 hours
children 4 years to under 6 years15 mL (1 dose cup) every 4 hours
children under 4 yearsdo not use.

Other information

OTHER SAFETY INFORMATION

  • each 15 mL contains: Sodium 7.5 mg
  • store at room temperature 20-30°C (68-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, 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.
Fort Worth, TX. 76118

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TexaClear Kids Daytime Cough and Chest Congestion
NDC 58809-216-08
8 fl. oz. (237 mL)

Dextromethorphan HBR – Cough Suppressant
Guaifenesin – Expectorant

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

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

Ages 4+

Relieves:

  • Chest Congestion
  • Thins & Loosens Mucus
  • Cough

Distributed by:
GM Pharmaceuticals, Inc. Fort Worth, TX 76118

PDPPDP

Drug FactsDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-216TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GM PHARMACEUTICALS, INC]2Unmatched20241010_f9cdc7a2-1972-4cb8-9234-6220f40c2b8c.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-21658809-216-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
4120accf-8825-aef4-e063-6394a90a4dd7f9cdc7a2-1972-4cb8-9234-6220f40c2b8c2025-10-14WarningsExact identifier
spl set id: f9cdc7a2-1972-4cb8-9234-6220f40c2b8c

Reported adverse events (FAERS/openFDA)#

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