Label: TEXACLEAR KIDS ALLERGY- chlophedianol hcl pyrilamine maleate liquid

  • NDC Code(s): 58809-925-08
  • 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 January 13, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients

    (in each 30 mL (2 TBSP))

    Chlophedianol HCl 12.5 mg

    Pyrilamine Maleate 25 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
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not exceed recommended dosage.

    Ask 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 the enlargment of the prostate gland
    • cough that occurs with too much phlegm(mucus)
    • a breathing problem such as emphysema or chronic bronchitis
  • Ask a doctor or pharmacist before use if you are

    • taking sedative or tranquilizers
  • When using this product

    • do not use more than directed
    • marked drowsiniess may occur
    • alcohol, secatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especiially 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 persisten headace. A persisten cough may be a sign of a serious condition.
    • new symptoms occur
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, as 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 per 24-hours.
    • Use enclosed dose cup and keep with product.
    • mL = mililiter

    Adults and children 12 years of age and over:60 mL (2 dose cups) every 6 to 8 hours
    Children 6 to under 12 years of age:30 mL (1 dose cup) every 6 to 8 hours
    Children under 6 years of age:Do not use.

  • Other Information

    ▪ each 30 mL contains: Sodium 14 mg

    ▪ read all product information before using

    ▪ store at room temperature 68-86°F (20-30°C

  • Inactive ingredients

    citric acid, glycerin,propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • Questions or comments?

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

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

    KEEP LEAFLET AFTER OPENING

  • PRINCIPAL DISPLAY PANEL

    TexaClear® Kids Allergy + Cough
    NDC 58809-925-08
    8 fl. oz. (237 mL)

    Chlophedianol HCl – Cough Suppressant
    Pyrilamine Maleate – Antihistamine

    Tamper evident: do not use if foil seal under cap is broken on missing

    • Gluten Free
    • Dye Free
    • Sugar Free
    • Alcohol Free
    • Acetaminophen Free

    Ages 6+
    Dose every 6 to 8 hours

    • Sneezing
    • Runny Nose
    • Watery Eyes
    • Itchy Nose & Throat
    • Cough

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

    label

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR KIDS ALLERGY 
    chlophedianol hcl pyrilamine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-925
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 30 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE25 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-925-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/15/2016
    Labeler - GM Pharmaceuticals, Inc. (793000860)