FDA.reportPublic FDA data

TexaClear Kids Cough and Cold

Manufacturer
GM Pharmaceuticals, INC
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:20:03

Label at a glance#

ProductTexaClear Kids Cough and Cold
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
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 nasal congestion due to a cold   stuffy nose 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 ■ use enclosed (30 mL) dose cup  ■ mL = milliliter ■ dose every 4 hours ■ adults and children 12 years and over:60 mL (2 dose cups) ■ children 6 to under 12 years: 30 mL (1 dose cup) ■ children under 6 years: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TexaClear® Kids Daytime Cough & Cold

(dextromethorphan hbr, guaifenesin, phenylephrine hcl), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant
Nasal decongestant

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
  • nasal congestion due to a cold  
  • stuffy nose
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings 

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use

OTC - DO NOT USE SECTION

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • in children under 6 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease, thyroid disease, diabetes, or high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days, or are accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

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 6 doses per 24-hour period

■ use enclosed (30 mL) dose cup  ■ mL = milliliter

■ dose every 4 hours

■ adults and children 12 years and over:60 mL (2 dose cups)

■ children 6 to under 12 years: 30 mL (1 dose cup)

■ children under 6 years: do not use

Other information

OTHER SAFETY INFORMATION

  • each 30 mL contains:  Sodium 1 5 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, 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.
Arlington, TX. 76015

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TexaClear® Kids Daytime Cough & Cold

NDC 58809-950-08

8 fl. oz. (237 mL)

Dextromethorphan HBR – Cough Suppressant

Guaifenesin – Expectorant

Phenylephrine HCL – Nasal Decongestant

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+

Relieves:

  • Nasal & Chest Congestion
  • Thins & Loosens Mucus
  • Cough

Distributed by:

GM Pharmaceuticals, Inc. Arlington, TX 76015

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Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-95058809-950-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
0b282f06-3147-8ed1-e063-6294a90a6cd53bc591c6-2f94-5cbe-e054-00144ff8d46c2023-11-27WarningsExact identifier
spl id: 0b282f06-3147-8ed1-e063-6294a90a6cd5
spl set id: 3bc591c6-2f94-5cbe-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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