Label: GILTUSS CHILDRENS ALLERGY PLUS COUGH AND CONGESTION- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

  • NDC Code(s): 58552-139-04
  • 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 5 mL)

    Chlorpheniramine maleate USP, 2 mg

    Dextromethorphan HBr USP, 10 mg

    Phenylephrine HCl USP, 5 mg

  • PURPOSE

    Purposes

    Antihistamine

    Cough Suppressant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves
    • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
    • nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily restores freer breathing through the nose
  • WARNINGS

    Warnings

    Do not use

    • to sedate a child or to make a child sleepy
    • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

    Ask a doctor or pharmacist before use if the child is

    • taking sedatives or tranquilizers
    • taking any other oral nasal decongestant or stimulant

    When using this product

    • do not use more than directed
    • may cause marked drowsiness
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • nervousness, dizzyness, or sleepless occurs
    • symptoms do not get better within 7 days or are accompanied by a fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

    These could be signs of a serious condition.

    If pregnant or breastfeeding,ask a health professional before use.

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • not take more than 6 doses in any 24-hour period
    • use enclosed dosing cup
    • keep dosage cup for use with this product
    • mL=milliter
    children under 6 yearsConsult a Doctor
    children 6 to under 12 years5 mL every 4 to 6 hours
    adults and children 12 years and over10 mL every 4 to 6 hours
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    citric acid, flavor, glycerin, methylparaben, 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

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

    MANUFACTURED FOR

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

    giltuss.com

  • PRINCIPAL DISPLAY PANEL

    Children's

    Giltuss® ALLERGY PLUS COUGH & CONGESTION

    ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

    Alcohol Free. Sodium Free. Sugar Free. Dye Free.

    • SNEEZING
    • RUNNY NOSE
    • COUGH
    • ITCHY & WATERY EYES
    • STUFFY NOSE
    • SINUS PRESSURE

    TUTTI FRUTTI FLAVOR

    4 FL OZ (118 mL)

    58552-139 Child Allergy Cough Congestion

  • INGREDIENTS AND APPEARANCE
    GILTUSS CHILDRENS ALLERGY PLUS  COUGH AND CONGESTION
    chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-139
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Coloryellow (Light yellow) Score    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-139-041 in 1 CARTON11/07/2018
    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 DrugM01211/07/2018
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58552-139)
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