Label: CHEST CONGESTION- guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 6, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Guaifenesin, USP 100 mg

  • Purpose

    Expectorant

  • Uses

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

  • 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 6½ TSP to 1 TSP
    6 to under 121 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.

  • 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.
  • 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.

  • Questions?

    877-434-2036

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    CHEST CONGESTION 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-163-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2013
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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