TEXACLEAR KIDS CONGESTION STUFFY NOSE- phenylephrine hydrochloride liquid

TexaClear Kids Congestion Stuffy Nose by

Drug Labeling and Warnings

TexaClear Kids Congestion Stuffy Nose by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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)

INGREDIENTS AND APPEARANCE

TEXACLEAR KIDS CONGESTION STUFFY NOSE 
phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-940
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-940-08	24 in 1 BOX	08/01/2019
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/01/2019

Labeler - GM Pharmaceuticals, INC (793000860)