Label: ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ- dextromethorphan hydrobromide, guaifenesin tablet, effervescent

  • NDC Code(s): 0280-0089-01, 0280-0089-02
  • Packager: Bayer Healthcare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

    Dextromethorphan hydrobromide 10 mg………….…Cough suppressant

    Guaifenesin 200 mg.......…………….….................................Expectorant

  • PURPOSE

  • Uses

    Uses

    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold
    • the intensity of coughing
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • WARNINGS

    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.

    ● if you have ever had an allergic reaction to this product or any of its Ingredients

    ● in children under 12 years of age

    Ask a doctor before use if you have

    ● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● a sodium-restricted diet

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a 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

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

  • Directions

    Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • OTHER SAFETY INFORMATION

    Other information
    ● each tablet contains: potassium 80 mg; sodium 237 mg

    ● store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

    anhydrous citric acid, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium bicarbonate, sucralose

  • Questions or comments

    Questions or comments? 1-800-986-0369 (Mon - Fri 9AM - 5PM EST)

  • Carton 24 count

    ASP Cough and Chest Congestion Cool Blueberry Pomegranate 24ctAlka Seltzer Plus Maximum Strength Cough & Chest Congestion

    POWERFAST FIZZ™

    Dextromethorphan HBr / Cough Suppressant

    Guaifenesin/Expectorant

    24 EFFERVESCENT TABLETS

  • INGREDIENTS AND APPEARANCE
    ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ 
    dextromethorphan hydrobromide, guaifenesin tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0089
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POVIDONE (UNII: FZ989GH94E)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;CandC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0089-0120 in 1 CARTON04/05/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0089-0212 in 1 CARTON03/08/2023
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/05/2022
    Labeler - Bayer Healthcare LLC. (112117283)