TEXACLEAR KIDS COUGH AND COLD (DEXTROMETHORPHAN HBR GUAIFENESIN PHENYEPHRINE HCL) LIQUID [GM PHARMACEUTICALS, INC]

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TEXACLEAR KIDS COUGH AND COLD (DEXTROMETHORPHAN HBR GUAIFENESIN PHENYEPHRINE HCL) LIQUID [GM PHARMACEUTICALS, INC]
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NDC 58809-950-08
Set ID 3bc591c6-2f94-5cbe-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager GM Pharmaceuticals, INC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    TexaClear® Kids Daytime Cough & Cold

    (dextromethorphan hbr, guaifenesin, phenylephrine hcl), solution

    GM Pharmaceuticals, Inc.

    Drug Facts

  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Cough suppressant
    Expectorant
    Nasal decongestant

  • 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
    • nasal congestion due to a cold  
    • stuffy nose
    • 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

    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • in children under 6 years of age

    Ask a doctor before use if you have

    • heart disease, thyroid disease, diabetes, or high blood pressure
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • trouble urinating due to an enlarged prostate gland
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    taking any other oral nasal decongestant or stimulant

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days, or are accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

    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 6 doses per 24-hour period

    ■ use enclosed (30 mL) dose cup  ■ mL = milliliter

    ■ dose every 4 hours

    ■ adults and children 12 years and over:60 mL (2 dose cups)

    ■ children 6 to under 12 years: 30 mL (1 dose cup)

    ■ children under 6 years: do not use

  • Other information

    • each 30 mL contains: Sodium 15 mg
    • read all product information before using
    • store at room temperature 68-86°F (20-30°C)
  • 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.
    Arlington, TX. 76015

  • Principal Display Panel

    TexaClear® Kids Daytime Cough & Cold
    NDC 58809-950-08
    8 fl. oz. (237 mL)

     

    Dextromethorphan HBR – Cough Suppressant
    Guaifenesin – Expectorant
    Phenylephrine HCL – Nasal Decongestant

    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+

    Relieves:

    • Nasal & Chest Congestion
    • Thins & Loosens Mucus
    • Cough

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

    TexaClear® Kids Daytime Cough & Cold NDC 58809-950-08 8 fl. oz. (237 mL) Dextromethorphan HBR – Cough Suppressant Guaifenesin – Expectorant Phenylephrine HCL – Nasal Decongestant 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+ Relieves: • Nasal & Chest Congestion • Thins & Loosens Mucus • Cough Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR KIDS COUGH AND COLD 
    dextromethorphan hbr guaifenesin phenyephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-950
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 30 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 30 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:58809-950-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/15/2015
    Labeler - GM Pharmaceuticals, INC (793000860)
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