Label: GILTUSS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

  • NDC Code(s): 65852-012-04
  • Packager: Dextrum Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 18, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Drug FactsActive Ingredients ( in each 5 mL)

    Dextromethorphan HBr , 15 mg

    Guaifenesin, 300 mg

    Phenylephryne HCl, 10 mg

  • Purpouse Section & Uses

    Cough supressant

    Expectorant

    Nasal Descongestant

    Uses

    temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold. Purpose and uses

  • Warnings

    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 dont know if your prescription drug contains and MAOI , ask a doctor or pharmacist before taking this product, Warnings

  • Ask a Doctor

    Ask a doctor before use if you have, heart disease, high blood pressure, thryroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor, cough with too much phlegm ( mucus), a persistent or chronic cough as occurs with smoking, asthma,chronic bronchitis, or ephysema Ask a Doctor

  • Ask a doctor or pharmacist

    Ask a doctor o pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives , tranquilizer, and drugs used for depression, especially monoamine oxidase inhibitors (MAOI's) Ask a doctor or pharmacist

  • Stop use

    Stop useStop use and ask a doctor if, nervousness, dizziness, or sleeplessness occur, sympton do not get better within 7 days or are accompanied by fever, cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition.

  • Pregnancy or breast feeding

    Pregnancy or breast feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly. If pregnant

  • Directions

    Directions, do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

    Adults and children 12 years & over 5 ml every 4 hours

    children 6 to under 12 years age 2.5 ml every 4 hours

    children 4 to 6 years of age 1.25 ml every 4 hours

    children under 6 years of age Consult a doctor Directions

  • other information

    Other information

    Store at room temperature , between 15-30 oC

    Keep thigtly closed

    Save carton for complete drug facts other information

  • Inactive Ingredients

    Inactive Ingredients

  • Questions

    Questions

    Call 1-787-848-9114, Monday-Friday 9 AM --5PM EST

    Call your doctor for medical advice in the event of side effects. Questions

  • Keep out of reach of children

    Keep out

    Keep out of reach of children section

    In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.

  • Indication and usage section

    Indication and usage section

    Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

    Adults and children 12 years & over 5 ml every 4 hours

    children 6 to under 12 years age 2.5 ml every 4 hours

    children 4 to 6 years of age 1.25 ml every 4 hours

    children under 6 years of age Consult a doctor

    indication an user

  • Principal panel

    maximun strength

    Giltuss Cold & cold

    Alcohol free

    Sugar free

    Dye free

    Cough, Phlem & Stuffy nose

    Non-drowsy

    Cherry flavor

    4 flox 118 ml Principal panel

  • INGREDIENTS AND APPEARANCE
    GILTUSS COUGH AND COLD 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65852-012-041 in 1 CARTON10/02/2018
    1113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/02/2018
    Labeler - Dextrum Laboratories Inc. (007392322)