Label: SANATOS CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hydrobromide and guaifenesin liquid

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

Drug Label Information

Updated May 2, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    (in each 5 mL teaspoonful)     		Purpose
    Dextromethorphan HBr, USP 5 mgCough Suppressant
    Guaifenesin, USP 100 mgExpectorant
  • Uses

    • 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 id the child has

    • cough that occurs with too much phlegm (mucus)
    • 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

    • cough lasts more than 7 days, comes back or occurs with 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 Poison Control Center right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    AgeDose
    Children 6 years to under 12 years1-2 teaspoonful s (tsps) every 4 hours
    Children 4 years to under 6 years½-1 teaspoonful (tsp) every 4 hours
    Children under 4 yearsdo not use
  • Other information

    • each teaspoon contains: sodium 3 mg
    • store between 20-25 C (68-77 F)
    • do not refrigerate
    • dosage cup provided
    • Keep cartoon for full directions for use
  • Inactive ingredients

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

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

  • SPL UNCLASSIFIED SECTION

    Distributed by
    PHARMDEL®
    Seaford, DE 19973

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC # 55758-007-04

    SanaTos®

    Children's

    Mucus Relief
    COUGH
    Cherry Flavor

    Dextromethorphan HBr
    Cough Suppressant

    Guafenesin
    Expectorant

    Relieves Chest Congestion
    Thins & Loosens Mucus

    Alcohol-Free
    For Ages 4 to 12

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SANATOS CHILDRENS MUCUS RELIEF COUGH 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-007
    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)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-007-041 in 1 CARTON10/10/201301/01/2026
    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 DrugM01210/10/201301/01/2026
    Labeler - Pharmadel LLC (030129680)
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