Label: EXPECTORANT COUGH CHILDRENS- dextromethorphan hydrobromide and guaifenesin liquid 

  • Label RSS
  • NDC Code(s): 55312-419-26
  • Packager: Western Family Foods 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 09/12

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

  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

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  • Purpose

    Cough suppressant

    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
    temporarily relieves:
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    the intensity of coughing
    the impulse to cough to help your child get to sleep
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  • Warnings

    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

    cough that occurs with too much phlegm (mucus)
    persistent or chronic cough such as occurs with asthma

    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 condition.

    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)

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  • Directions

    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    do not use dosing cup with other products
    mL = milliliter

    Age

    Dose

    children 6 years to under 12 years

    5 mL - 10 mL every 4 hours

    children 4 years to under 6 years

    2.5 mL – 5 mL every 4 hours

    children under 4 years

    do not use

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  • Other information

    store at 20-25 oC (68-77 oF)
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  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

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  • Principal Display Panel

    FOR AGES 4 TO 12

    Children’s Expectorant Cough

    GUAIFENESIN 100mg – EXPECTORANT

    DEXTROMETHORPHAN HBr 5mg – COUGH SUPPRESSANT

    COUGH

    CHEST CONGESTION

    LOOSENS MUCUS

    ALCOHOL-FREE

    Gluten Free

    CHERRY FLAVOR LIQUID

    COMPARE TO ACTIVE INGREDIENTS OF CHILDREN’S MUCINEX® COUGH

    Children's Expectorant Cough Carton Image 1
    Children's Expectorant Cough Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    EXPECTORANT COUGH  CHILDRENS
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55312-419
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    D&C RED NO. 33  
    FD&C RED NO. 40  
    GLYCERIN  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM DIHYDRATE  
    SODIUM BENZOATE  
    SORBITOL  
    XANTHAN GUM  
    ANHYDROUS CITRIC ACID  
    Product Characteristics
    Color RED (Dark Red) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-419-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/26/2007
    Labeler - Western Family Foods Inc (192166072)
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