Label: ABANATUSS PED- chlophedianol hydrochloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride 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 November 13, 2019

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

  • Drug Facts

  • Active Ingredients (in each 5mL tsp)

    Chlophedianol HCL, 25 mg

    Dexchlorpheniramine Maleate, 2 mg

    Pseudoephedrine HCL, 60 mg

  • Purpose

    Cough Suppressant

    Antihistamine

    Nasal Decongestant

  • 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 right away.

  • 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 • controls cough impulse without narcotics • temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other 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 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 as MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if your child has • diabetes • heart disease • thyroid disease • high blood pressure • 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 • glaucoma • breathing problem such as emphysema or chronic bronchitis.

    Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers

    When using this product do not exceed recommended dosage • may cause excitability especially in children • may cause marked drowsiness, alcohol, sedatives and tranquilizers may increase the drowsiness effect • avoid alcoholic beverages while taking this product • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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 a persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

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

     Adults and Children 12 years of age and over5 mL (1 tsp), every 6 hours
     Children 6 to under 12 years of age 2.5 mL (1/2 tsp), every 6 hours
     Children under 6 years of age Consult physician

  • INACTIVE INGREDIENT

    Inactive Ingredients citric acid, flavors, propylene glycol, sodium benzoate, sorbitol, sucralose and water

  • STORAGE AND HANDLING

    Other information • Store at controlled room temperature 15°-30°C (59°-86°F) • protect from freezing • protect from light • Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing.

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for Kramer Novis, San Juan, PR 00917. Tel: (787) 767-2072 / www.kramernovis.com

    * Panatuss® PED is a registered trademark of Seyer Pharmatec. This product is not manufactured, distributed or marketed by Seyer Pharmatec.

    Contains the same active ingredients as Panatuss® PED*

    SUGAR FREE

    DYE FREE

    ALCOHOL FREE

    GLUTEN FREE

    TROPICAL FRUIT FLAVOR

  • Packaging

    ped1

  • INGREDIENTS AND APPEARANCE
    ABANATUSS PED 
    chlophedianol hydrochloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-675
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE25 mg  in 5 mL
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorFRUIT (Tropical fruit) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-675-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2015
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)