Label: PECGEN DMX  - guaifenesin and dextromethorphan hydrobromide syrup 

  • Label RSS
  • 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 02/13

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

  • ACTIVE INGREDIENT

    Active Ingredients/5 ml: guaifenesin 125 mg dextromethorphan hydrobromide 15 mg

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  • PURPOSE

    Cough suppressant, expectorant

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  • INDICATIONS & USAGE

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. restores free breathing.

    suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

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  • WARNINGS

    Do not:
    • use more than the recommended dose
    • give this product to a child who has heart disease, high blood pressure, thyroid
    disease, or diabetes unless directed by a doctor.
    • use if you are now 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 prescription drug contains an MAOI, ask a doctor or
    pharmacist before taking this product.
    • 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.
    Ask a doctor before use if you have
    When using this product do not use more than directed
    Stop use and ask a doctor if
    •you get nervous, dizzy, or sleepless
    •symptoms do not get better within 7 days or are accompanied by fever
    •Coughs 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.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of the reach of children

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  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product

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  • INACTIVE INGREDIENT

    Inactives: Citric Acid, FDC Red 40, Flavor, Glycerin, Methylparaben, propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose

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  • PRINCIPAL DISPLAY PANEL

    MM1

    PecgenDMX

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  • DOSAGE & ADMINISTRATION

    Directions Adults and Children 12 years of age and over 10 mL (2 tsp)
    Children 6 to under 12 years of age 5 mL (1 tsp) E V E RY
    6 HOURS
    do not take more than 4 doses in any 24-hour period
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  • INGREDIENTS AND APPEARANCE
    PECGEN DMX  
    guaifenesin,dextromethorphan hydrobromide syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52083-620
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 125 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    METHYLPARABEN  
    PROPYLPARABEN  
    PROPYLENE GLYCOL  
    SODIUM CITRATE  
    SUCRALOSE  
    WATER  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (SWEET C HERRY) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52083-620-16 480 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/29/2011
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(52083-620)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(52083-620)
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