TEXACLEAR KIDS CONGESTION STUFFY NOSE- phenylephrine hydrochloride liquid 
GM Pharmaceuticals, INC

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TexaClear Kids Congestion Stuffy Nose

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)

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)

TEXACLEAR KIDS CONGESTION STUFFY NOSE 
phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-940
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-940-0824 in 1 BOX08/01/201910/31/2024
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/01/201910/31/2024
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2023
Document Id: 0b282941-3f2d-0cb1-e063-6394a90ac4fd
Set id: 46ee7b0a-4d5d-48f6-a855-79c81ee9ac6a
Version: 4
Effective Time: 20231127
 
GM Pharmaceuticals, INC