Label: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet

  • NDC Code(s): 69367-198-90
  • Packager: Westminster Pharmaceuticals, LLC
  • 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 January 19, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Dextromethorphan HBr 17.5mgCough Suppressant
    Guaifenesin 385mgExpectorant
    Phenylephrine HCl 10mgNasal Decongestant
  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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.

    Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlargement of the prostate gland

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
    • A persistent cough may be a sign of a serious condition.
    • new symptoms occur

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

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
    Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
    Children under 6 years of age:Consult a doctor.
  • Other Information

    Store at 15°-30°C (59°-86°F)

    Supplied in a tight, light-resistant container with a child-resistant cap. Dextromethorphan HBr; Guaifenisan; Phenylephrine HCl tablets are orange, oblong, capsule shaped, scored tablets, debossed "WP" bisect "198" on one side and plain on the other.

  • Inactive ingredients

    FD&C Yellow #6, D&C Yellow #10, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

  • Questions? Comments?

    Call 1-844-221-7294

  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    NDC 69367-198-90

    Dextromethorphan HBr
    Guaifenesin
    Phenylephrine HCl

    Cough Suppressant • Expectorant
    Nasal Decongestant

    Each tablet contains:

    Dextromethorphan HBr
    17.5 mg

    Guaifenesin
    385 mg

    Phenylephrine HCl
    10 mg

    90 Tablets

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-198
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide17.5 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin385 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code WP;198
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-198-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/25/2018
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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