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Panatuss (Seyer Pharmatec, Inc.)

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LIQUID 60 mL in 1 BOTTLE (11026-2662-2) Label Information

Complete Panatuss Information

  • ACTIVE INGREDIENT


     Active Ingredients (per 1 mL)                                                          Purpose

    Dexbrompheniramine Maleate   0.5 mg............................................................................Antihistamine

    Dextromethorphan HBr   5 mg...................................................................................Cough Suppressant

    Phenylephrine HCl   2.5 mg........................................................................................Nasal Descongestant


  • PURPOSE

     Uses

    •  Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold.
    • Temporarily relieves nasal congestions due to common cold.
    • For temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or allergic rhinitis.

  • WARNINGS


      Warnings:

    Do not use: in child who is taking a prescription monoamine oxidase inhibitor (MAOI), (certain drugs for prescription, 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. May cause excitability especially in children. Do not take this product, if you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, heart disease, high blood pressure, diabetes, or thyroid disease, unless directed by a doctor. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.


  • DO NOT USE


    When using this product:

    • Use only as directed by physician


    Stop use and ask a doctor if
    • Your child gets nervous, dizzy, or sleepless
    • Condition lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, consult a doctor.

  • DOSAGE & ADMINISTRATION

    Directions

    • To be taken by mouth only. Not for nasal use.
    • Children 6 years of age to under 12 years; 2 mL every 4 - 6 hours.
    • Children under 6 years of age: Consult a doctor.
    • Do not exceed 4 doses in 24 hours.




  • INDICATIONS & USAGE

    Other Information:

    • Warning: Phenylketonorics contains phenylalanine 1.5 mg per 1 mL
    • Store at 15-30 degrees celcius(59-86 degrees fahrenheit)
    • Alcohol Free and Phenylpropanolamine (PPA) Free
    • Wrapped calibrated syringe (enclosed)
    TAMPER-EVIDENT DISCLOSURE: Do not use this product if printed foil under cap is torn, broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    aspartame, D and C red 33, flavor, methylparaben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propylparaben, purified water, and sucrose.


  • QUESTIONS

    Any questions or comments please call: (888) 782 - 3585

    Seyer Pharmatec, Inc. Guaynabo, Puerto Rico 00970


  • INGREDIENTS AND APPEARANCE
    PANATUSS  PEDIATRIC DROPS DXP
    dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11026-2662
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 0.5 mg  in 1 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11026-2662-2 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/01/2005
    Labeler - Seyer Pharmatec, Inc. (832947126)
    Registrant - Seyer Pharmatec, Inc. (832947126)