Label: CHEST CONGESTION- guaifenesin solution 

  • Label RSS
  • NDC Code(s): 45014-163-04
  • Packager: Accudial Pharmaceutical, Inc.
  • 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL = 1 teaspoon)

    Guaifenesin, USP 100 mg

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  • Purpose

    Expectorant

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  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

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  • WARNINGS

    Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma.

    Directions

    • may be given every 4 hours
    • do not use more than 6 times in 24 hours
    • use only enclosed dosing cup to dose this product. Do not use any other dosing device.

    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.

    Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

    Age (yr) Dose (TSP)
    TSP = teaspoon
    under 4 yrs. ask a doctor
    4 to under 6 ½ TSP to 1 TSP
    6 to under 12 1 TSP to 2 TSP
    or as directed by a doctor

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

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  • Other information

    • each teaspoon contains: sodium 3 mg
    • store between 20°-25°C (68°-77°F)
    • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
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  • Inactive ingredients

    artificial flavor, citric acid, corn syrup FD&C blue #1, D&C red #33, glycerin, purified water sodium benzoate, sodium saccharin, sucralose, xanthan gum.

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  • Questions?

    877-434-2036

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  • SPL UNCLASSIFIED SECTION

    Distributed by: AccuDial® Pharmaceutical, Inc.
    Palm Beach Gardens, FL 33408

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    ACCUDIAL®
    Children's
    Chest
    Congestion

    Guaifenesin
    Oral Solution Expectorant

    Relieves Chest Congestion
    Thins & Loosens Mucus

    Earth-Friendly
    Package!

    For Ages 4 yrs to under 12 yrs

    Tamper Evident

    Compares to
    Mucinex® For Kids

    GRAPE
    FLAVOR

    NDC 45014-163-04
    4 FL. OZ. (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    CHEST CONGESTION 
    guaifenesin solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45014-163
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid Monohydrate  
    Corn Syrup  
    FD&C Blue No. 1  
    D&C Red No. 33  
    Glycerin  
    Water  
    Sodium Benzoate  
    Saccharin Sodium  
    Sucralose  
    Xanthan Gum  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45014-163-04 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 02/01/2013
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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