Label: TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin liquid

  • NDC Code(s): 58809-216-08
  • 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
  • SPL UNCLASSIFIED SECTION

    TexaClear Kids Daytime Cough and Chest Congestion

    (dextromethorphan HBr, guaifenesin), solution

    GM Pharmaceuticals, Inc.

    Drug Facts

  • Active ingredients (in each 15 mL)

    Dextromethorphan HBr 5 mg
    Guaifenesin 100 mg

  • Purpose

    Cough suppressant
    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
    • temporarily relieves:
      • the intensity of coughing
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • WARNINGS

    Do not exceed recommended dosage.

    Do not use

    in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, pschiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    • persistent or chronic cough such as occurs with asthma
    • a cough that occurs with too much phlegm (mucus)
    • a sodium-restricted diet

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

    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 6 doses per 24-hour period.
    • measure only with the dosing cup provided.
    • mL= milliliter
    AgeDose
    children 6 years to under 12 years30 mL (2 dose cups) every 4 hours
    children 4 years to under 6 years15 mL (1 dose cup) every 4 hours
    children under 4 yearsdo not use.
  • Other information

    • each 15 mL contains: Sodium 7.5 mg
    • store at room temperature 20-30°C (68-86°F)
  • Inactive ingredients

    citric acid, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, 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

  • Principal Display Panel

    TexaClear Kids Daytime Cough and Chest Congestion
    NDC 58809-216-08
    8 fl. oz. (237 mL)

    Dextromethorphan HBR – Cough Suppressant
    Guaifenesin – Expectorant

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

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

    Ages 4+

    Relieves:

    • Chest Congestion
    • Thins & Loosens Mucus
    • Cough

    Distributed by:
    GM Pharmaceuticals, Inc. Fort Worth, TX 76118

    PDP

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-216
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 15 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-216-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/25/2023
    Labeler - GM Pharmaceuticals, INC (793000860)
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!