Label: TEXACLEAR- allergy relief tablet

  • NDC Code(s): 58809-186-30
  • 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 3, 2023

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  • SPL UNCLASSIFIED SECTION

    TEXACLEAR-ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET

    GM Pharmaceuticals, Inc.

    TexaClear Allergy Relief Tablet 30 count

    Drug Facts

  • Active Ingredients (per tablet)

    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:
      • runny nose
      • itchy, watery eyes
      • itching of the nose or throat
      • sneezing
      • 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
    • 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, 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 tablets per 24-hour period.
    adults and children 12 years and older:take 1 tablet every 6 to 8 hours.
    children under 12 years:do not use.
  • Other Information

    • tamper evident: do not use if foil seal under the cap is broken or missing
    • This package is child-resistant.
    • read all information before using
    • store at room temperature 20-30°C (68-86°F)
    • avoid excess heat and humidity
  • Inactive Ingredients

    croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, stearic acid

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-186-30

    TEXACLEAR

    ALLERGY

    RELIEF

    30 Tablets

    TexaClear Fast Acing Allergy Relief

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR 
    allergy relief tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE25 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code AC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-186-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2015
    Labeler - GM Pharmaceuticals, INC (793000860)
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