Label: CREOMULSION FOR CHILDREN- dextromethorphan hydrobromide syrup 

  • Label RSS
  • NDC Code(s): 12090-0015-0, 12090-0015-1
  • Packager: Summit Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 01/13

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

  • Active Ingredient

    In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg

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  • Purpose

    Cough Suppressant

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  • Uses

    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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  • Warnings

    Do not use if you are now taking 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 prescription drug contains an MAOI, ask a doctor or a pharmacist before taking the product.

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  • Ask a doctor before use if you

    • have cough that occurs with too much phlegm (mucus)
    • have cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
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  • Stop use and ask a doctor if

    • cough lasts more than 7 days comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    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 take more than 6 doses in any 24 period. Use enclosed dose cup.
    Children under 4 years do not use
    Children 4 years to under 6 years 5ml (1tsp) every 4 hours
    Children 6 years to under 12 years 10ml (2tsp) every 4 hours
    Children 12 years and over 20ml (4tsp) every 4 hours

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  • Other Information

    • store at 20-25°C (68-77°F)
    • packaged with tamper evident seal around cap
    • contains no alcohol
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  • Inactive Ingredients

    caramel, citric acid, corn syrup, FD and C Red No. 40, flavor, menthol, potassium sorbate, purified water, sodium benzoate, sucrose

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  • Questions or Comments

    Call 8am - 4pm Est. Mon - Thurs 1-800-241-6996

    Money Back Guarantee

    Guaranteed to give desired results or your money back.

    Send carton top, reason for dissatisfaction, sales receipt, lot number, and your phone number to Summit Industries, Inc.

    P.O. Box 7329, Marietta, GA 30065

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  • DESCRIPTION

    How Creomulsion For Children Works:

    Gentle Creomulsion For Children is specially formulated for a child's delicate system.

    It contains the most effective cough suppressant available without a prescription.

    It calms the urge to cough, while Creomulsion's smooth consistency soothes your child's throat.



    For Adult coughs and colds...

    Creomulsion Cough Medicine

    Adult Formula

    Fast effective relief from coughs due to cold or other bronchial irritations.


    Summit Industries, Inc.

    P.O. Box 7329

    Marietta, GA 30065

    creomulsion.com

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  • Image of Carton and Label

    CreomulsionChildren.jpgCreomulsion Children Carton CreomulsionChildrenBackLabel.jpgCreomulsion Children Label

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  • INGREDIENTS AND APPEARANCE
    CREOMULSION  FOR CHILDREN
    dextromethorphan hydrobromide syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:12090-0015
    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
    Inactive Ingredients
    Ingredient Name Strength
    CARAMEL  
    CITRIC ACID MONOHYDRATE  
    CORN SYRUP  
    FD&C RED NO. 40  
    MENTHOL  
    POTASSIUM SORBATE  
    WATER  
    SODIUM BENZOATE  
    SUCROSE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12090-0015-0 1 in 1 CARTON
    1 NDC:12090-0015-1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part341 12/30/2009
    Labeler - Summit Industries, Inc. (003279189)
    Registrant - Summit Industries, Inc. (003279189)
    Establishment
    Name Address ID/FEI Business Operations
    Summit Industries, Inc. 003279189 manufacture(12090-0015)
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