FDA.reportPublic FDA data

TexaClear Kids Congestion Stuffy Nose

Manufacturer
GM Pharmaceuticals, INC
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:20:03

Label at a glance#

ProductTexaClear Kids Congestion Stuffy Nose
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

■ temporarily relieves:  ■ stuffy nose  ■ sinus congestion and pressure ■ temporarily restores freer breathing through the nose

Dosage and administration

■ do not exceed 6 doses per 24 hours   ■ mL = milliliter ■ use enclosed (15 mL) dose cup and keep with product children 6 to under 12 years of age       30 mL (2 dose cups) every 4 hours children 2 to under 6 years of age       15 mL (1 dose cup) every 4 hours children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 15 mL)

Phenylephrine HCI 2.5 mg

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves:

 ■ stuffy nose  ■ sinus congestion and pressure

■ temporarily restores freer breathing through the nose

Warnings

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 (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 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

■ heart disease       ■ high blood pressure

■ thyroid disease       ■ diabetes

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occur

■ symptoms do not improve within 7 days or occur with a fever

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not exceed 6 doses per 24 hours   ■ mL = milliliter

■ use enclosed (15 mL) dose cup and keep with product

children 6 to under 12 years of age       30 mL (2 dose cups) every 4 hours

children 2 to under 6 years of age       15 mL (1 dose cup) every 4 hours

children under 2 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

■ each 15 mL contains: Sodium 6 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, sorbitol, sucralose

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 58809-940-08
TexaClear
Kids
CONGESTION
STUFFY NOSE
Phenylephrine HCI- Nasal Decongestant
FREE & CLEAR
8 fl oz (237 mL)

NDC 58809-940-08 TexaClear Kids CONGESTION STUFFY NOSE Phenylephrine HCI- Nasal Decongestant FREE & CLEAR 8 fl oz (237 mL)NDC 58809-940-08 TexaClear Kids CONGESTION STUFFY NOSE Phenylephrine HCI- Nasal Decongestant FREE & CLEAR 8 fl oz (237 mL)
NDC 58809-940-08 TexaClear Kids CONGESTION STUFFY NOSE Phenylephrine HCI- Nasal Decongestant FREE & CLEAR 8 fl oz (237 mL)NDC 58809-940-08 TexaClear Kids CONGESTION STUFFY NOSE Phenylephrine HCI- Nasal Decongestant FREE & CLEAR 8 fl oz (237 mL)

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-94058809-940-08

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 BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
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
0b282941-3f2d-0cb1-e063-6394a90ac4fd46ee7b0a-4d5d-48f6-a855-79c81ee9ac6a2023-11-27WarningsExact identifier
spl id: 0b282941-3f2d-0cb1-e063-6394a90ac4fd
spl set id: 46ee7b0a-4d5d-48f6-a855-79c81ee9ac6a

Reported adverse events (FAERS/openFDA)#

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