Label: PANATUSS PED- chlophedianol hydrchloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops

  • 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 May 22, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients                         Purpose
    (in each 1 mL)

    Chlophedianol HCl 6.25 mg ...................... Cough Suppressant

    Dexchlorpheniramine Maleate 0.5 mg ......... Antihistamine

    Pseudoephedrine HCl 15 mg ................... Nasal Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Antihistamine

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold

    • calms the cough control center and relieves coughing
    • non narcotic cough suppressant for the temporary relief of cough
    • temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other upper respiratory allergies
    • temporarily relieves nasal congestion due to the common cold
    • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  • WARNINGS

    Warnings

    • do not exceed recommended dosage
    • a persistent cough may be 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
    Ask a doctor before use if a child has
    • a persistent or chronic cough such as occurs with asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    Ask a doctor before use if a child is taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedatives and tranquilizers may increase the drowsiness effect
  • DO NOT USE


    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 taking this product
    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occur
    • if symptoms do not improve within 7 days or are accompanied by fever, rash or persistent headache.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • take every 6 hours, not to exceed 4 doses in 24 hours or as directed by a physician

    Children 6 to under 12 years of age
    2 mL
    Children 2 to under 6 years of age
    Ask a doctor
    Children under 2 years of age
    Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    Citric acid, flavor, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments?1-888-782-3585

  • PRINCIPAL DISPLAY PANEL

    panatusspeddrops

  • INGREDIENTS AND APPEARANCE
    PANATUSS PED 
    chlophedianol hydrchloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2785
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE6.25 mg  in 1 mL
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE0.5 mg  in 1 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorFRUIT (Tropical Fruit) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11026-2785-21 in 1 CARTON
    160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/15/2012
    Labeler - Seyer Pharmatec, Inc. (832947126)