Label: ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent

  • 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 April 17, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

    Acetaminophen 250 mg…………….………...Pain reliever/fever reducer

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

    Dextromethorphan hydrobromide 10 mg……………Cough suppressant

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

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    · temporarily relieves these symptoms due to a cold or flu:

    · minor aches and pains · headache · cough

    · sore throat · runny nose · sneezing

    · nasal and sinus congestion

    · temporarily reduces fever

  • WARNINGS

    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 before use if you have

    ● liver disease ● heart disease ● high blood pressure

    ● thyroid disease ● diabetes ● glaucoma

    ● cough with excessive phlegm (mucus)

    ● a breathing problem such as emphysema or chronic bronchitis

    ● difficulty in urination due to enlargement of the prostate gland

    ● persistent or chronic cough such as occurs with smoking, asthma,

    or emphysema

    ● a sodium restricted diet

    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 childre


    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

  • 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 8 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, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer®

    PLUS

    SEVERE

    Cold

    & Flu

    CITRUS

    POWERFAST FIZZ™

    NEW IMPROVED FLAVOR

    ACETAMINOPHEN/Pain Reliever-Fever Reducer

    Chlorpheniramine Maleate/Antihistamine

    Dextromethorphan HBr/ Cough Supressant

    Phenylephrine Hydrochloride/Nasal Decongestant

    • Fever & Body Ache
    • Cough
    • Nasal Congestion
    • Runny Nose
    • Sore Throat

    20 EFFERVESCENT TABLETS

    Carton 20 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ 
    chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (Speckled) Scoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code ASP;FLU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0022-0110 in 1 CARTON04/01/2020
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)