Label: RESFRIDOL ANTITUSSIVE- guaifenesin, dextromethorphan hbr suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 12, 2022

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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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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 BOX08/01/2019
    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 finalpart34108/01/2019
    Labeler - Laboratorios Alfa (815941244)
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