FDA Label for Texaclear Kids Congestion Stuffy Nose
View Indications, Usage & Precautions
Texaclear Kids Congestion Stuffy Nose Product Label
The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
(in each 15 mL)
Phenylephrine HCI 2.5 mg
Purpose
Nasal Decongestant
Uses
■ temporarily relieves:
■ stuffy nose ■ sinus congestion and pressure
■ temporarily restores freer breathing through the nose
Warnings
Do not exceed recommended dosage.
Do Not Use
■ 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
■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes
Stop Use And Ask A Doctor If
■ nervousness, dizziness, or sleeplessness occur
■ symptoms do not improve within 7 days or occur with a fever
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
■ 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
■ 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
citric acid anhydrous, glycerin, 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.
Principal Display Panel
NDC 58809-940-08
TexaClear
Kids
CONGESTION
STUFFY NOSE
Phenylephrine HCI- Nasal Decongestant
FREE & CLEAR
8 fl oz (237 mL)
* Please review the disclaimer below.
