Label: ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS CONGESTION AND PAIN POWERFAST FIZZ- chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride tablet, effervescent

  • NDC Code(s): 0280-0055-01, 0280-0055-02
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

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

    Acetaminophen 325 mg…………….………...Pain reliever/fever reducer

    Chlorpheniramine maleate 2 mg……………………..……..Antihistamine

    Dextromethorphan hydrobromide 10 mg……………Cough suppressant

    Phenylephrine hydrochloride 5 mg………………….Nasal decongestant

  • PURPOSE

  • Uses

    temporarily relieves these symptoms due to a cold or flu:

    • minor aches and pains
    • headache
    • cough
    • sore throat
    • runny nose
    • sneezing
    • nasal congestion · sinus

    temporarily reduces fever

  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    · more than 4,000 mg of acetaminophen in 24 hours

    · with other drugs containing acetaminophen

    · 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin or severe

    allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than

    2 days, is accompanied or followed by fever, headache, rash, nausea,

    or vomiting, consult a doctor promptly.

    Do not use to sedate children.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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 or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts. These
    • could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    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 10 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 356 mg

    store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Asp Sinus Congestion and Pain Berry 24ctAlka-Seltzer Plus®

    MAXIMUM STRENGTH

    Sinus

    Congestion

    & Pain

    PowerFast Fizz™

    Berry

    New!

    Actaminophen/Pain Reliever-Fever Reducer

    Chlorpheniramine Maleate/Antihistamine

    Dextromethorphan HBr/Cough Supressant

    Phenylephrine Hydrochloride/Nasal Decongestant

    • Sinus Congestion & Pressure
    • Nasal Congestion
    • Headache, Body Ache, Sore Throat
    • Runny Nose, Sneezing
    • Cough

    24 EFFERVESCENT TABLETS

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS CONGESTION AND PAIN POWERFAST FIZZ 
    chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0055
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    MANNITOL (UNII: 3OWL53L36A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorBERRY (Raspberry and Mixed Berry) Imprint Code SINUS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0055-0110 in 1 CARTON06/15/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0055-0212 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 finalpart34106/15/2021
    Labeler - Bayer HealthCare LLC. (112117283)
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