Label: RESFRIDOL ANTITUSSIVE- guaifenesin, dextromethorphan hbr suspension

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

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

  • Active ingredients and Purposes

    Active ingredients (in each 10 mL)Purposes
    Guaifenesin 200 mg ............................................................................Expectorant
    Dextromethorphan HBr 30 mg..................................................Cough suppressant

  • Uses

    Temporarily relieves common cold symptoms:

    • cough due to minor throat & bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to:
    • drain bronchial tubes
    • make coughs more productive
  • Warnings

    Ask a doctor or pharmacist before 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 MAOI drug. If you do not know if your prescription drug contains an MAOI.
    • have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor if

    a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. 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 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.

  • Directions

    • do not exceed recommended dosage
    • do not exceed 4 doses in a 24-hour period
    • adults & children 12 year of age & over: 1 teaspoonful (10 mL), every 6 hours
    • children 6 to under 12 years of age: 1/2 teaspoonful (5 mL), every 6 hours
    • children under 6 years of age: do not use
  • Other information

  • Other information

    • store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.
  • Other information

    • store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.
  • Inactive ingredients

    artificial flavors, citric acid, FD&C red no.40, sodium benzoate, sorbitol, sucralose, water

  • Questions?

    +1-809-544-0222 (M-F) 9 AM to 5 PM Eastern or www.laboratoriosalfa.com

  • Principal Display Panel

    Resfridol

    Antitussive

    Syrup

    • Cough Suppressant
    • Expectorant

    Dextromethorphan Hbr and Guaifenesin

    4 fl oz (120mL)

    Resfridol Antitussive

  • INGREDIENTS AND APPEARANCE
    RESFRIDOL ANTITUSSIVE 
    guaifenesin, dextromethorphan hbr suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72483-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72483-100-041 in 1 BOX08/01/201911/27/2024
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/201911/27/2024
    Labeler - Laboratorios Alfa (815941244)
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