Label: ACTINEL- dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 4, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ​Drug Facts

  • Active Ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, 15 mg
    Guaifenesin, 200 mg
    Pseudoephedrine HCl, 30 mg

  • Purposes

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • ​Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

  • Warnings

    Do not 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, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have
    • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

    When using this product do not use more than directed.

    Stop use and ask a doctor if
    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by 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 breast-feeding, 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. 

  • Directions

    • do not take more than 4 doses in any 24-hour period.

    AGEDOSE
    Adults and children 12 years
    of age and over 
    Take 2 teaspoonfuls
    (10 mL) every 6 hours
     Children under 12 years of
    age
     do not use

  • Other information

    • Tamper Evident Feature: Do not use if inner seal is torn, cut, or opened
    • Store at controlled room temperature 15°- 30°C (59° - 86°F)
    • Avoid excessive heat or humidity.

  • Inactive ingredients

    Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

  • Questions or comments?

    call weekdays from 8AM to 4PM AST at 1.787.608.0882

  • SPL UNCLASSIFIED SECTION

    NEW FORMULA

    Contains the same active ingredients as Tusnel®*

    SUGAR FREE
    DYE FREE
    ALCOHOL FREE
    SACCHARIN FREE

    COMMITTED TO HEALTH AND WELL-BEING
    WWW.ACTIPHARMA.NET 

    Manufactured in USA with imported ingredients for ActiPharma, Inc.
    San Juan, PR 00917.

    * Tusnel® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

  • Packaging

    ACTINEL-101

  • INGREDIENTS AND APPEARANCE
    ACTINEL 
    dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-101-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/24/2014
    Labeler - Actipharma, Inc (079340948)