TEXACLEAR FAST ACTING ALLERGY RELIEF- chlophedianol hydrochloride, pyrilamine maleate 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 Fast Acting Allergy Relief

(Chlophedianol HCI & Pyrilamine Maleate), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Chlophedianol HCl 25 mg 

Pyrilamine Maleate 50 mg

Purpose

Cough suppressant

Antihistamine

Uses

■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:

      ■ runny nose

      ■ sneezing

      ■ itching of the nose or throat

      ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Warnings

Ask a doctor before use if you have

■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if you are

■ taking sedative 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

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

■ new symptoms occur

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 4 doses in any 24 hour period

■ use enclosed dose cup and keep with product

■ mL= milliliter

■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs

■ children under 12 years of age: do not use

Other information

■ each 30 mL contains: Sodium 17 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, sodium saccharin, sorbitol

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 58809-360-08
TEXACLEAR
FAST ACTING
ALLERGY
RELIEF
8 fl oz (237 mL)

Texaclear PDP
TexaClear Drug Facts
TEXACLEAR FAST ACTING ALLERGY RELIEF 
chlophedianol hydrochloride, pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE25 mg  in 30 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-360-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/21/2014
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 8/2023
Document Id: 03207e46-c44f-7b8e-e063-6294a90a5739
Set id: 17a2f643-fa98-21ee-e054-00144ff88e88
Version: 8
Effective Time: 20230817
 
GM Pharmaceuticals, INC