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

Drug Label Information

Updated November 29, 2023

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

View All Sections
  • 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:

    • itchy nose or throat
    • sneezing
    • itchy, watery eyes
    • runny nose
    • cough due to minor throat and bronchial irritation
  • Warnings

    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.
    Fort Worth, TX 76118

    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. Fort Worth, TX 76118

    PDP

    Drug Facts

  • 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 DrugM1206/15/2016
    Labeler - GM Pharmaceuticals, Inc. (793000860)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sovereign Pharmaceuticals, LLC623168267manufacture(58809-925)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!