Label: DEXTROMETHORPHAN HBR,GUAIFENESIN capsule, liquid filled

  • NDC Code(s): 35916-0760-1
  • Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2026

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

  • Active ingredient (in each soft gelatin capsule)

    Dextromethorphan HBr USP 10mg

    Guaifenesin USP 200mg

  • PURPOSE

    Purposes

    Cough suppresent

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
  • WARNINGS

    Warnings

  • DO NOT USE

    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 DOCTOR

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm(mucus)
  • WHEN USING

    When using this product do not use more than directed

  • STOP USE

    Stop use and ask a doctor if

    • cough lasts more than 7 days,comes back,or occur with fever, rash, or headache that lasts.

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 12 liquid gels in any 24-hour period
    • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
    • children under 12 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    bulk label

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR,GUAIFENESIN 
    dextromethorphan hbr,guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0760
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorgreen (Opaque) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0760-11000 in 1 BAG; Type 0: Not a Combination Product03/21/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/21/2025
    Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (676666501)