Label: G-XPECT PSE- dextromethorphan hydrobromide, guaifenesin, and pseudoephedrine hydrochloride liquid

  • 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 April 23, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL, teaspoonful)Purpose
    Guaifenesin 200 mgExpectorant
    Dextromethorphan HBr 10 mgCough Suppressant
    Pseudoephedrine HCI 30 mgNasal Decongestant
  • Indications

    • For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
    • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
    • Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
    • Temporarily helps you cough less.
  • Warnings

    • Do not exceed recommended dosage.
      If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.
    • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

    • Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
    • Do not 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.

    • A persistent cough may be the sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache, consult a doctor.

    • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

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

    • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    • Keep this and all drugs out of the reach of children.
  • Directions

    Do not take more than 6 doses in any 24-hour period.

    Adults and children 12 years of age and over2 teaspoonfuls (10 mL) every 4 hours
    Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 hours
    Children under 6 years of ageConsult a doctor
  • Inactive Ingredients

    Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose.

  • Other Information

    Store at 20°-25°C (68°-77°F)

    Tamper evident by seal under cap. Do not use if the seal is broken or missing.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC-43913-407-16

    G-Xpect PSE

    Cough Suppressant, Expectorant & Nasal Decongestant

    Sugar Free • Dye Free • Alcohol Free • Phenylalanine Free

    Grape Flavor

    16 FL OZ (473 mL)

    Multiple Dose Unit Package
    For Dispensing Under Pharmaceutical Supervision Only

    McLaren Medical

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    G-XPECT PSE 
    dextromethorphan hydrobromide, guaifenesin, and pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-407
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sorbitol (UNII: 506T60A25R)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43913-407-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/11/2014
    Labeler - McLaren Medical (013770591)
    Registrant - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    NameAddressID/FEIBusiness Operations
    davAgen Pharmaceutical, LLC967545935MANUFACTURE(43913-407) , PACK(43913-407) , LABEL(43913-407) , ANALYSIS(43913-407)
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