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

  • Category: HUMAN OTC DRUG LABEL

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 January 13, 2022

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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 age2.5 mL every 4 hours
      Children under 2 years of ageask 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 finalpart34110/17/2017
    Labeler - Pharmadel LLC (030129680)
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