Label: CREOMULSION FOR CHILDREN- dextromethorphan hydrobromide syrup

  • NDC Code(s): 70893-0012-0, 70893-0012-1
  • Packager: Socius Care, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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

  • Active Ingredient

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

  • Purpose

    Cough Suppressant

  • Uses

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

  • 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.
  • 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.
  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • Directions

    • Do not take more than 6 doses in any 24 period. Use enclosed dose cup.
    Children 6 years to under 12 years10mL (2tsp) every 4 hours
    Children 2 to under 6 years5mL (1tsp) every 4 hours
    Children under 2 yearsDo not use

  • Other Information

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

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

  • Questions or Comments

    Call 8am - 4pm Est. Mon - Fri. 1-404-566-8896

    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 Socius Care, LLC

    3939 Royal Dr. NW, Suite 230, Kennesaw, GA 30144

  • 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.

  • Image of Carton and Label

    Creomulsion For Children CartonCreomulsion For Children Back Label

  • INGREDIENTS AND APPEARANCE
    CREOMULSION  FOR CHILDREN
    dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70893-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70893-0012-01 in 1 CARTON08/11/2016
    1NDC:70893-0012-1118 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/11/2016
    Labeler - Socius Care, LLC (079946712)