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

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

Drug Label Information

Updated October 4, 2023

If you are a consumer or patient please visit this version.

  • ​Drug Facts

  • Active Ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, 5 mg
    Guaifenesin, 50 mg
    Pseudoephedrine HCl, 15 mg

  • Purposes

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:
       • nasal congestion 
       • cough due to minor throat and bronchial irritation 

  • 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 giving this product.

    Ask a doctor before use if your child has
    • heart disease • high blood pressure • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with asthma

    Ask a doctor or pharmacist before use if your child is 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 child
    • gets 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 
    Children 6 to under 12 years 
    of age
    Take 2 teaspoonfuls
    (10 mL) every 4-6 hours
    Children 2 to under 6 years of
    age 
    Take 1 teaspoonfuls
    (5 mL) every 4-6 hours 
     Children under 2 years of ageAsk a doctor 

  • 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

    Contains the same active ingredients as Tusnel® Pediatric*

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

  • Packaging

    Pediatric-102

  • INGREDIENTS AND APPEARANCE
    ACTINEL PEDIATRIC 
    dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 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
    ColorpinkScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-102-16474 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)