Label: G-P-TUSS DXP - dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each 5mL tsp) Purpose
    Dexbrompheniramine Maleate, 2 mg Antihistamine
    Dextromethorphan Hydrobromide, 20 mg Cough suppressant
    Phenylephrine HCl, 10 mg Nasal Decongestant
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  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • sneezing
      • itchy nose or throat
      • runny nose
      • itchy, watery eyes
      • nasal congestion
    • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
    • temporarily restores freer breathing through nose
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  • 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 the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema.

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

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • new symptoms occur
    • symptoms do not improve 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 accidental overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • do not take more than 6 doses in any 24-hour period
    • EVERY 4 HOURS
    • Adults and Children 12 years of age and older: 5 mL (1 tsp)
    • Children 6 to under 12 years of age: (2.5 mL (1/2 tsp)
    • Children under 6 years of age: consult physician
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  • Other information

    • Tamper evident feature: Do not use if inner seal is torn, broken or missing
    • Store at controlled room temperature 15-30°C (59-86°F)
    • Avoid excessive heat or humidity
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  • Inactive ingredients

    Ammonium glycyrrhizinate, D&C red #33, flavor, glycerin, hydroxyethylcellulose, methylparaben, polysorbate, propylparaben, purified water, and sucralose

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - G-P-TUSS DXP

    Principal Display Panel

    NDC 52083-602-16

    G-P-TUSS DXP

    ANTIHISTAMINE
    COUGH SUPPRESSANT
    NASAL DECONGESTANT

    ALCOHOL FREE
    RASPBERRY FLAVOR

    16 Fl. oz. (473 mL)
    Kramer Novis

    Pharmaceuticals within reach of patients

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  • INGREDIENTS AND APPEARANCE
    G-P-TUSS DXP 
    dexbrompheniramine, dextromethorphan, and phenylephrine syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52083-602
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE 2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    AMMONIUM GLYCYRRHIZATE  
    D&C RED NO. 33  
    GLYCERIN  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
    METHYLPARABEN  
    POLYSORBATE 20  
    PROPYLPARABEN  
    WATER  
    SUCRALOSE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor RASPBERRY (Raspberry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52083-602-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/24/2013
    Labeler - Kramer Novis (090158395)
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