Label: SANATOS MUCUS RELIEF COLD TODDLERS- dextromethorphan hbr, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 13, 2023

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  • Drug Facts

  • Active Ingredients & Purposes

    Active ingredients (in each 2.5 mL)Purposes
    Dextromethorphan HBr 2.5 mg .....

    Cough suppressant
    Guaifenesin 50 mg............Expectorant

  • Use

    • 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 drain the bronchial tubes
  • 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 is accompanied by excessive phlegm (mucus) or
    • persistent or chronic cough such as occurs with asthma

    When using this product

    do not use more than directed

    Stop use and ask a doctor, if the child has a

    cough persists for more than 1 week, tends to recur, or is accompanied by 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.

  • Directions

    • do not give a child more than 6 doses in any 24-hour period
    • repeat the dose every 4 hours
    • measure with the dosing device provided
    • do not use any other dosing device

    AgeDose
    children 2 to under 6 years of age 2.5 mL every 4 hours
    children under 2 years of age ask a doctor



  • Other information

    • each dose (2.5 mL) contains: sodium 1.5 mg
    • store between 20-25°C (68-77°F)
    • oral dosing device included
    • do not refrigerate
    • Keep carton for full direction for use
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

  • Questions or comments?

    1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • Principal Display Panel

    Sanatos

    Toddlers

    Mucus Relief

    Cough

    Dextromethorphan HBr........Cough Suppressant

    Guaifenesin...............................................Expectorant

    FOR CHILDREN 2 TO UNDER 6 YEARS

    Cherry Flavor

    2 FL OZ (59 mL)

    • ALCOHOL FREE
    • NON-DROWSY


    Includes Syringe

    Sanatos Toddlers

  • INGREDIENTS AND APPEARANCE
    SANATOS MUCUS RELIEF COLD TODDLERS 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 2.5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 2.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTITOL (UNII: D65DG142WK)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-307-0259 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/17/2017
    Labeler - Pharmadel LLC (030129680)
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