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

  • 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 December 4, 2018

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

  • ​Drug Facts 

  • Active Ingredients (in each 5mL tsp)

    Dextromethorphan HBr, 5mg

    Guaifenesin, 50 mg

    Pseudoephedrine HCl, 15 mg

  • Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • Uses:

    temporarily:
    • relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
    • relieves sinus congestion and pressure, helps decongest sinus openings and passages
    • restores freer breathing through the nose
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
    • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

  • Warnings:

    • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

    Do not:
    • give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
    • use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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.
    • give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.

    Stop use and ask a doctor if:
    • symptoms do not improve within 7 days or are accompanied by fever

    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. Prompt medical attention is critical for adults as well as for children even if you do not notice any sign or symptoms.

  • Directions:

    • Children 6-12 years, Take 2 teaspoons (10 ml) every 4-6 hours as needed, do not exceed 8 teaspoons in 24 hours, or as directed by a doctor.

    • Children 2-6 years, Take 1 teaspoon (5 ml) every 4-6 hours as needed, do not exceed 4 teaspoons in 24 hours, or as directed by a doctor.

    • Children under 2 years of age: consult a doctor.

  • Other Information

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

  • Inactive Ingredients:

    citric acid, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

  • SPL UNCLASSIFIED SECTION

    Contains the same active ingredients as Tusnel® Pediatric*

    Dextromethorphan HBr

    COUGH SUPPRESSANT

    Guaifenesin

    EXPECTORANT

    Pseudoephedrine HCl

    NASAL DECONGESTANT

    ALCOHOL FREE

    COST –EFFECTIVE SOLUTIONS

    Manufactured in the USA for ActiPharma, Inc, Dorado, PR 00646, Tel: (787) 608-0882

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

  • Packaging

    Actinel pediatric

  • 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    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 finalpart34109/24/2014
    Labeler - Actipharma, Inc (079340948)