Texaclear Fast Acting Allergy Relief

Texaclear Fast Acting Allergy Relief

Drug Labeling and Warnings

Drug Details

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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

TEXACLEAR FAST ACTING ALLERGY RELIEF

(Chlophedianol HCI & Pyrilamine Maleate), solution

GM Pharmaceuticals, Inc.

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GM Pharmaceuticals, Inc. TEXACLEAR FAST ACTING ALLERGY RELIEF

Drug Facts

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 (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days, tends 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 recommended dosage.
  • do not take more than 4 doses in any 24-hour period
  • dose as follows or as directed by a doctor
  • use enclosed dosing cup
  • do not use dosing cup with other products
  • mL = milliliters
adult and children 12 years and over30mL every 6-8 hours
children under 12do not use

Other information

  • each 30 mL contains: Sodium 17 mg.
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • Read all product information before using
  • store at 68° to 86°F (20° to 30°C).
  • avoid excessive heat and humidity

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- 5p.m CST

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

PRINCIPAL DISPLAY PANEL

NDC: 58809-360-08
TEXACLEAR
Fast Acting
ALLERGY
RELIEF
8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL
NDC: <a href=58809-360-08 TEXACLEAR Fast Acting ALLERGY RELIEF 8 fl oz (237 mL) " src="https://fda.report/DailyMed/17a2f643-fa98-21ee-e054-00144ff88e88/texaclear-fast-acting-allergy-relief-01.jpg&archiveid=305088"/>

PRINCIPAL DISPLAY PANEL
NDC: <a href=58809-360-08 TEXACLEAR Fast Acting ALLERGY RELIEF 8 fl oz (237 mL) " src="https://fda.report/DailyMed/17a2f643-fa98-21ee-e054-00144ff88e88/texaclear-fast-acting-allergy-relief-02.jpg&archiveid=305088"/>

PRINCIPAL DISPLAY PANEL
NDC: <a href=58809-360-08 TEXACLEAR Fast Acting ALLERGY RELIEF 8 fl oz (237 mL) " src="https://fda.report/DailyMed/17a2f643-fa98-21ee-e054-00144ff88e88/texaclear-fast-acting-allergy-relief-03.jpg&archiveid=305088"/>

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: 1/2018
 
GM Pharmaceuticals, INC


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