Label: GUAIFENESIN,DEXTROMETHORPHAN HBR capsule, liquid filled

  • NDC Code(s): 35916-0759-3, 35916-0759-4
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 27, 2026

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

  • Active ingredient (in each soft gelatin capsule)

    Guaifenesin USP 400mg

    Dextromethorphan HBr USP 20mg

  • PURPOSE

    Purposes

    Expectorant

    Cough suppressant

  • INDICATIONS & USAGE

    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 rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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

    • cough accompained by excessive phlegm(mucus)
    • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
  • When using this product

    • do not exceed recommended dosage
    • do not use for more than 7 days
  • STOP USE

    Stop use and ask a doctor if

    • cough lasts for more than 7 days,recurs, or is accompanied by fever, rash, or persistent headache .

    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 accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not exceed 6 doses in 24 hours
    • take with a full glass of water
    • adults and children 12 years of age and over: take 1 softgel every 4 hours
    • children under 12 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F)
    • Keep in dry place and do not expose to heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN,DEXTROMETHORPHAN HBR 
    guaifenesin,dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0759
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Coloryellow (Clear transparent) Scoreno score
    ShapeCAPSULE (Oblong) Size22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0759-32 in 1 BOX09/15/2025
    12000 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:35916-0759-42 in 1 BOX01/13/2026
    21500 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/11/2025
    Labeler - Softgel Healthcare Pvt Ltd (676666501)