Label: TEXACLEAR KIDS CONGESTION STUFFY NOSE- phenylephrine hydrochloride liquid

  • NDC Code(s): 58809-940-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each 15 mL)

    Phenylephrine HCI 2.5 mg

  • Purpose

    Nasal Decongestant

  • Uses

    ■ temporarily relieves:

     ■ stuffy nose  ■ sinus congestion and pressure

    ■ temporarily restores freer breathing through the nose

  • Warnings

    Do not exceed recommended dosage.

    Do not use

    ■ in a child who is 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 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

    ■ heart disease       ■ high blood pressure

    ■ thyroid disease       ■ diabetes

    Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleeplessness occur

    ■ symptoms do not improve within 7 days or occur with a fever

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    ■ do not exceed 6 doses per 24 hours   ■ mL = milliliter

    ■ use enclosed (15 mL) dose cup and keep with product

    children 6 to under 12 years of age       30 mL (2 dose cups) every 4 hours

    children 2 to under 6 years of age       15 mL (1 dose cup) every 4 hours

    children under 2 years of age: consult a doctor

  • Other information

    ■ each 15 mL contains: Sodium 6 mg

    ■ read all product information before using

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

  • Inactive ingredients

    citric acid anhydrous, 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.

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-940-08
    TexaClear
    Kids
    CONGESTION
    STUFFY NOSE
    Phenylephrine HCI- Nasal Decongestant
    FREE & CLEAR
    8 fl oz (237 mL)

    NDC 58809-940-08 TexaClear Kids CONGESTION STUFFY NOSE Phenylephrine HCI- Nasal Decongestant FREE & CLEAR 8 fl oz (237 mL)
    NDC 58809-940-08 TexaClear Kids CONGESTION STUFFY NOSE Phenylephrine HCI- Nasal Decongestant FREE & CLEAR 8 fl oz (237 mL)

  • INGREDIENTS AND APPEARANCE
    TEXACLEAR KIDS CONGESTION STUFFY NOSE 
    phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-940
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-940-0824 in 1 BOX08/01/201910/31/2024
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/201910/31/2024
    Labeler - GM Pharmaceuticals, INC (793000860)
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