Label: CHILDRENS TUSSIN DM liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 March 1, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Active Ingredient: Dextromethorphan HBr 5mg, Guaifenesin 100mg (in each 5 mL)

  • PURPOSE

    Purpose:
    Cough suppressant
    Expectorant

  • INDICATIONS & USAGE

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to coughs more productive
  • WARNINGS

    DO NOT USE IF PRINTED SEAL OVER IS TORN OR MISSING

    Warnings:

    Do not use if 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
  • WHEN USING

    Stop use and ask 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In case of overdose, seek professional assistance or contact a Poison control center right away.

  • PREGNANCY OR BREAST FEEDING

  • DOSAGE & ADMINISTRATION

    Directions:

    • This product does not contain directions or complete warnings for adult use.
    • Use only enclosed dosing cup provided.
    • Do not take more than 6 doses in any 24-hour period.
    • Children 6 years to under 12 years: 5 mL – 10 mL taken every 4 hours.
    • Children 4 years to under 6 years: 2.5 mL – 5 mL taken every 4 hours.
    • Children under 4 years: do not use.
  • STORAGE AND HANDLING

    Other information

    • each teaspoon contains: sodium 4 mg
    • store at 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients
    Anhydrous citric acid, Artificial & Natural flavors, FD&C Blue#1, FD&C red 40, Sucralose, Glycerin, Polyethylen Glycol, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Benzoate

  • HOW SUPPLIED

    (packs: 4oz) Kingston NDC# 71027-036-04

    Manufactured by: Kingston Pharma LLC
    5 County Route 42
    Massena, NY 13662

  • PRINCIPAL DISPLAY PANEL

    Label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS TUSSIN DM 
    childrens tussin dm liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71027-032-041 in 1 CARTON03/01/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2017
    Labeler - KINGSTON PHARMA LLC (080386521)
    Registrant - KINGSTON PHARMA LLC (080386521)
    Establishment
    NameAddressID/FEIBusiness Operations
    KINGSTON PHARMA LLC080386521manufacture(71027-032)
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