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

Drug Label Information

Updated October 7, 2024

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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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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 DrugM01210/21/2014
    Labeler - GM Pharmaceuticals, INC (793000860)