TEXACLEAR KIDS SINUS RELIEF- phenylephrine hcl thonzylamine hcl liquid 
GM Pharmaceuticals, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TEXACLEAR KIDS SINUS RELIEF

TexaClear® Kids Congestion Sinus Relief

(phenylephrine hcl, thonzylamine hcl) solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Phenylephrine HCl 5 mg

Thonzylamine HCI 50 mg

Purpose

Nasal decongestant

Antihistamine

Uses

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

▪ nasal congestion

▪ reduces swelling of the nasal passages

▪ runny nose

▪ sneezing

▪ itchy, watery eyes

▪ itching of the nose or throat

Warnings

Do not use

▪ 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

▪ high blood pressure, heart disease, diabetes, or thyroid disease

▪ difficulty in urination due to enlargement of the prostate gland

▪ glaucoma

▪ a breathing problem such as emphysema or chronic bronchitis

▪ a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

▪ taking any other oral nasal decongestant or stimulant

▪ taking sedatives or tranquilizers

When using this product

▪ do not use more than directed

▪ marked drowsiness may occur

▪ alcohol, sedatives, and tranquilizers may increase drowsiness

▪ avoid alcoholic drinks

▪ use caution when driving a motor vehicle or operating machinery

▪ excitability may occur, especially in children

Stop use and ask a doctor if

▪ symptoms do not improve within 7 days or are accompanied by fever

▪ new symptoms occur

▪ nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

▪ do not exceed 6 doses per 24 hrs

▪ use enclosed dose cup and keep with product

▪ mL= milliliter

adults & children 12 yrs & over:60 mL every 4 hrs
children 6 to under 12 yrs:30 mL every 4 hrs
children under 6 yrs:do not use.

Other information

▪ each 30 mL contains: Sodium 12 mg

▪ tamper evident: Do not use if foil seal under cap is broken or missing

▪ read all product information before using

▪ store at room temperature 68-86°F (20-30°C)

▪ avoid excessive heat and humidity

Inactive ingredients

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

Questions or comments?

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

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

KEEP LEAFLET AFTER OPENING

R041417

Principal Display Panel

TexaClear® Kids Congestion Sinus Relief

NDC 58809-945-08

8 fl. oz. (237 mL)

U.S. Pat: 9,050,289

Phenylephrine HCL – Nasal Decongestant

Thonzylamine HCL - 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+

Relieves:

  • Itchy Nose & Throat
  • Itchy, Watery Eyes
  • Runny Nose
  • Sneezing
  • Clears Nasal Passages

Distributed by:

GM Pharmaceuticals, Inc. Arlington, TX 76015

Principal Display Panel 
TexaClear® Kids Congestion Sinus Relief
NDC 58809-945-08
8 fl. oz. (237 mL)
U.S. Pat: 9,050,289
 
Phenylephrine HCL – Nasal Decongestant 
Thonzylamine HCL - 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+

Relieves:
•	Itchy Nose & Throat
•	Itchy, Watery Eyes
•	Runny Nose
•	Sneezing
•	Clears Nasal Passages

Distributed by: 
GM Pharmaceuticals, Inc. Arlington, TX 76015

Principal Display Panel 
TexaClear® Kids Congestion Sinus Relief
NDC 58809-945-08
8 fl. oz. (237 mL)
U.S. Pat: 9,050,289
 
Phenylephrine HCL – Nasal Decongestant 
Thonzylamine HCL - 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+

Relieves:
•	Itchy Nose & Throat
•	Itchy, Watery Eyes
•	Runny Nose
•	Sneezing
•	Clears Nasal Passages

Distributed by: 
GM Pharmaceuticals, Inc. Arlington, TX 76015

TEXACLEAR KIDS SINUS RELIEF 
phenylephrine hcl thonzylamine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-945
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8) THONZYLAMINE HYDROCHLORIDE50 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-945-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/201501/16/2019
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2019
 
GM Pharmaceuticals, INC