Label: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE liquid

  • NDC Code(s): 69367-184-08
  • 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 November 29, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 15 mL (TBSP)Purpose
    Dextromethorphan HBr 18 mgCough Suppressant
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 10 mgNasal Decongestant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleeo
      • nasal congestion due to a cold
  • Warnings

    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.

    Ask a doctor before use if you have

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

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistant 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 Poison Control Center right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • use enclosed dosage cup or tabelspoon (TBSP)
    • dose as follows or as directed by doctor.
    Adults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period
    Children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period
    Children under 6 years of age:Consult a doctor.
  • Other information

    • Each 15 mL (TBSP) contains Sodium 8 mg.
    • store at 68°-86°F (20°-30°C)
  • Other ingredients

    citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, rasberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol.

  • Questions or Comments?

    • Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.
  • PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

    NDC 69367-184-08

    Cough
    Cold/Congestion

    Dextromethorphan HBr
    Guaifenesin
    Phenylephrine HCl

    Each 15 mL (TBSP) contains:
    Dextromethorphan HBr 18 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 10 mg

    Cough Suppressant • Expectorant • Nasal Decongestant

    Rasberrry Flavor

    Alcohol Free/ Sugar Free
    Gluten Free/ Dye Free

    8 fl. oz. (240 mL)

    Westminster
    Pharmaceuticals

    Principal Display Panel - 240 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-184
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg  in 15 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-184-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/15/2018
    Labeler - Westminster Pharmaceuticals, LLC (079516651)