Label: GILTUSS CHILDRENS MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

  • NDC Code(s): 58552-137-04
  • Packager: Giltuss 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)

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg

    Dextromethorphan HBr 6.5 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Antihistamine

    Cough Suppressant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves:
    • minor aches and pains
    • headache
    • minor sore throat pain
    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy watery eyes due to hay fever
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • DO NOT USE

    Do not use

    • in a child under 4 years of age
    • if your child is allergic to acetaminophen or any inactive ingredient in this product
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • to make your child sleepy
  • ASK DOCTOR

    Ask a doctor or pharmacist before use if the child has

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as chronic bronchitis
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts such as occurs with asthma
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the child is

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • excitability may occur, especially in children

  • STOP USE

    Stop use and ask a doctor if

    • nervousness, dizzyness or sleeplessness
    • pain, nasal congestion, or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with fever, rash or headache that lasts.

    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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • use enclosed dosing cup
    • keep dosing cup for use with this product
    • mL = milliliter
    children under 6 years of ageDo not use
    children 6 to under 12 years of age5 mL every 4-6 hours, not to exceed 5 doses in 24 hours
    children 12 years and over10 mL every 4-6 hours, not to exceed 6 doses in 24 hours

  • OTHER SAFETY INFORMATION

    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, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, 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

    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

    Children's

    Giltuss® MULTI-SYMPTOM

    COLD & FLU

    ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

    Alcohol Free. Sodium Free. Sugar Free. Dye Free

    • FEVER, HEADACHE AND BODY ACHES
    • COUGH AND COLD
    • STUFFY NOSE
    • SNEEZING AND RUNNY NOSE

    STRAWBERRY FLAVOR

    4FL OZ (118 mL)

    58552-137 Child Multisymptom

  • INGREDIENTS AND APPEARANCE
    GILTUSS CHILDRENS MULTISYMPTOM COLD AND FLU 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-137
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE6.5 mg  in 5 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Coloryellow (Light yellow) Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-137-041 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 - Giltuss Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc007392322manufacture(58552-137)
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