Label: DR. SANA COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin liquid

  • NDC Code(s): 53113-514-06
  • Packager: GADAL Laboratories, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2025

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

  • Drug Facts

  • Active Ingredients: (in each 30ml)

    Dextromethorphan HBr 20 mg
    Guaifenesin 200 mg

  • Purpose

    Cough Suppressant
    Expectorant 

  • Uses

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

  • Warnings

    Do not use • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have • a cough that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions:

    do not exceed more than 6 doses in any 24-hour period
    shake well before use
    mL=milliliter

     age dose
     adults and children 12 years & more 2 tablespoons (30 mL) every 4 hours
     children under 12 years of age consult your doctor

  • Other information

    • Store this product between 15°C to 30°C (59° to 86°F)
    • Tamper evident feature: Do not use this product if imprinted cello-band over cap is torn, broken or missing.

  • Inactive ingredients:

    Aloe Vera, Citric Acid, Caramel Color, Corn Syrup, Eucalyptus Oil, Ginger Root PE, Honey, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.

  • Questions?

    call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900

  • SPL UNCLASSIFIED SECTION

    Relieves:
    COUGH
    CHEST CONGESTION

    with Natural Ingredients
    ALOE
    HONEY
    GINGER
    EUCALYPTUS

    NON DROWSY NO GLUTEN

    Distributed by:
    Healthtex Distributors, LLC
    Miami, Florida 33142
    info@healthtexusa.com

    Made in USA

    TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN BROKEN OR MISSING

  • Packaging

    CONGESTION DM

  • INGREDIENTS AND APPEARANCE
    DR. SANA COUGH AND CHEST CONGESTION DM 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-514
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARAMEL (UNII: T9D99G2B1R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GINGER (UNII: C5529G5JPQ)  
    HONEY (UNII: Y9H1V576FH)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-514-061 in 1 BOX04/14/2025
    1180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/14/2025
    Labeler - GADAL Laboratories, Inc (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639manufacture(53113-514)