Label: CHLO TUSS EX- chlophedianol hydrochloride and guaifenesin liquid 

  • Label RSS
  • NDC Code(s): 12830-767-15, 12830-767-16
  • Packager: R. A. McNeil Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/11

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

  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)

    Chlophedianol Hydrochloride 12.5 mg
    Guaifenesin 100 mg

    Purpose

    Cough Suppressant
    Expectorant
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  • Uses

    temporarily relieves these symptoms due to the common cold:
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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  • Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • a cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if

    • a cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
    • new symptoms occur

    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.
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  • Directions

    Do not exceed recommended dosage.
    Adults and children
    12 years of age
    and over:

    2 teaspoonfuls (10 mL)
    every 6 hours, not to
    exceed 8 teaspoonfuls
    in 24 hours
    Children 6 to under
    12 years of age:


    1 teaspoonful (5 mL)
    every 6 hours, not to
    exceed 4 teaspoonfuls
    in 24 hours
    Children under 6
    years of age:
    Consult a doctor


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  • Other information

    Store at 59°-86°F (15°-30°C).
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  • Inactive ingredients

    Berry Vanilla Flavor, Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose
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  • Questions? Comments?

    Call 1-423-493-9170
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  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel and side panel for 473 mL label:

    NDC 12830-0767-16

    Chlo Tuss EX

    Cough Suppressant • Expectorant

    Alchol Free • Gluten Free
    Sugar Free • Dye Free

    EACH 5 mL (1 TEASPOONFUL) CONTAINS:

    Chlophedianol HCl.........................12.5 mg
    Guaifenesin...................................100 mg

    Patent Pending

    Berry Vanilla Flavor

    ONE PINT (473 mL)

    Mfg. for R.A. McNeil Company
    Chattanooga, TN  37406-3738

    Rev. 08/11

    Tamper evident by foil seal under cap.  Do not
    use if foil seal is broken or missing.

    THIS BOTTLE IS NOT TO BE DISPENSED TO
    THE CONSUMER.


    Dispense in a tight, light-resistant container
    with a child-resistant cap.

    Patent Pending

    Manufactured for:
    R.A. McNeil Company
    1150 Latta Street
    Chattanooga, TN  37406-3738

    Rev. 08/11

    Chlo Tuss EX Packaging


    Chlo Tuss EX Packaging



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  • INGREDIENTS AND APPEARANCE
    CHLO TUSS  EX
    chlophedianol hydrochloride, guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:12830-767
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlophedianol Hydrochloride (Chlophedianol ) Chlophedianol Hydrochloride 12.5 mg  in 5 mL
    Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid  
    Glycerin  
    Propylene Glycol  
    Water  
    Sodium Citrate  
    Saccharin Sodium  
    Sorbitol  
    Sucralose  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BERRY (Berry Vanilla) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12830-767-16 473 mL in 1 BOTTLE
    2 NDC:12830-767-15 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/30/2011
    Labeler - R. A. McNeil Company (008305220)
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