Label: BRONCOLITO CHILDREN- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 23, 2026

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  • Drug Facts

    .

  • Active ingredients & Purposes

    .

    Active ingredients (in each 2.5 mL) Purposes

    Dextromethorphan HBr 5 mg......................Cough suppressant

    Guaifenesin 50 mg...............................................Expectorant

    Phenylephrine HCI 2.5 mg........................Nasal decongestant

  • Uses

    Temporarily relieves common cold symptoms:

    • stuffy nose
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    .

    Do not use

    • 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 your child has

    • heart disease high blood pressure
    • thyroid disease
    • diabetes
    • a cough that is accompanied by excessive phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, asthma

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if your child has

    • nervousness, dizziness, or sleeplessness occur
    • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    • only use the dosage cup included
    • do not exceed 6 doses in 24 hours

    AgeDose
    children 6 to under 12 yearstake 5 mL every 4 hours
    children 2 to under 6 yearstake 2.5 mL every 4 hours
    children under 2 yearsconsult a doctor

  • Other information

    • each 2.5 mL contains: sodium 1.5 mg
    • store between 68-77°F (20-25°C)
  • Inactive ingredients

    anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions?

    +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

  • Dist by/ por:

    PHARMADEL LLC

    New Castle, DE 19720

  • Principal Display Panel

    PDP Broncolito

  • INGREDIENTS AND APPEARANCE
    BRONCOLITO  CHILDREN
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 2.5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 2.5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 2.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HONEY (UNII: Y9H1V576FH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (Amber to yellow) Score    
    ShapeSize
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-520-081 in 1 CARTON07/01/2026
    1237 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 DrugM01207/01/2026
    Labeler - Pharmadel LLC (030129680)
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