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

  • NDC Code(s): 58552-130-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Dextromethorphan HBr, 15 mg

    Guaifenesin, 300 mg

    Phenylephrine HCI, 10 mg

  • PURPOSE

    Purposes

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
    • temporarily relieves nasal congestion due to a cold
  • Warnings

    Do not useif you are 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

    • heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache

    These can be signs of a serious condition.

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

    Keep out of reach of children.In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not exceed recommended dosage
    • do not take more than 6 doses in any 24 hour period
    • keep dosing cup for use with this product
    • mL = milliliters
    adults and children 12 years & over5 mL every 4 hours
    children 6 to under 12 years of age2.5 mL every 4 hours
    children 2 to 6 years of age1.25 mL every 4 hours
    children under 2 years of ageConsult a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • store at room temperature 15°- 30°C (59° - 86°F)
    • close cap tightlly
    • SAVE CARTON FOR COMPLETE DRUG FACTS
  • INACTIVE INGREDIENT

    Inactive ingredientsCitric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

  • QUESTIONS

    Questions or comments?

    Call 1-787-848-9114, Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

  • SPL UNCLASSIFIED SECTION

    Tamper evident: do not use if safety seal is broken or missing

    MANUFACTURED FOR

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    GILTUSS®

    COUGH & COLD

    ALCOHOL FREE. SUGAR FREE. DYE FREE

    RELIEVES

    • COUGH AND COLD
    • CHEST CONGESTION
    • LOOSENS PHLEGM AND MUCUS
    • STUFFY NOSE
    • NASAL CONGESTION
    • SINUS PRESSURE

    4 FL OZ (118 mL)

    58552-130

  • INGREDIENTS AND APPEARANCE
    GILTUSS COUGH AND COLD 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-130-041 in 1 CARTON10/02/2018
    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 DrugM01210/02/2018
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58552-130)
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