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

  • NDC Code(s): 58552-134-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)

    Dextromethorphan HBr, 20 mg

    Guaifenesin 200 mg

  • PURPOSE

    Purposes

    Cough Suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves
    • cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
  • 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 MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    When using this product do not use more than directed

    Ask a doctor before use if you have

    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as these could 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 accidental overdose, get medical or professional help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24-hour period
    • keep dosing cup with product
    • mL = milliliters
    Adults and children 12 years and over10 mL every 4 hours
    children 6 to under 12 years of age5 mL every 4 hours
    children 2 to under 6 years of age2.5 mL every 4 hours
    children under 2 years of ageDo not use

  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients:Citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water 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

    MANUFACTURED FOR

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

  • OTHER SAFETY INFORMATION

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

    PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT

    THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES

  • PRINCIPAL DISPLAY PANEL

    Giltuss® DIABETIC

    COUGH & COLD

    RELIEVES

    • COUGH AND COLD
    • CHEST CONGESTION
    • LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

    SAFE FOR PEOPLE WITH DIABETES

    GRAPE FLAVOR

    4 FL OZ (118 mL)

    58552-134

  • INGREDIENTS AND APPEARANCE
    GILTUSS DIABETIC  COUGH AND COLD
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-134-041 in 1 CARTON10/17/2018
    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 DrugM01210/17/2018
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58552-134)
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