Label: TEXACLEAR FAST ACTING ALLERGY RELIEF- chlophedianol hydrochloride, pyrilamine maleate liquid

  • NDC Code(s): 58809-360-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 17, 2023

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  • SPL UNCLASSIFIED SECTION

    (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
  • INGREDIENTS AND APPEARANCE
    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)
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