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
  • 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 August 16, 2023

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  • 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 finalpart34104/05/2022
    Labeler - Bayer Healthcare LLC. (112117283)
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