Label: ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 4, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

    Aspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducer

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

    Phenylephrine bitartrate 7.8 mg.......……....…....…………..Nasal decongestant

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to a cold with cough:
      • minor aches and pains
      • headache
      • sinus congestion and pressure
      • cough
      • sore throat
      • nasal congestion
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a

    doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    · hives · facial swelling · asthma (wheezing) · shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    ● are age 60 or older

    ● have had stomach ulcers or bleeding problems

    ● take a blood thinning (anticoagulant) or steroid drug

    ● take other drugs containing prescription or nonprescription NSAIDs

    (aspirin, ibuprofen, naproxen, or others)

    ● have 3 or more alcoholic drinks every day while using this product

    ● take more or for a longer time than directed

    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

    ● if you are allergic to aspirin or any other pain reliever/fever reducer

    ● 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 itsingredients

    ● in children under 12 years of age

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have
      • asthma •thyroid •disease diabetes
      • cough that occurs with excessive phlegm (mucus)
      • 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 a prescription drug for
      • gout
      • diabetes
      • arthritis

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • 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
    • ringing in the ears or loss of hearing occurs
    • 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.

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than the recommended dose
    • do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
    • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
    • children under 12 years: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: potassium 78 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, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

    Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer

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

    Doxylamine succinate 6.25 mg………………..…..………...…Antihistamine

    Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • headache
      • runny nose
      • sinus congestion and pressure
      • cough
      • sneezing
      • sore throat
      • nasal congestion
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling ·
    • asthma (wheezing)
    • shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • artake a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    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

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • 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

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have
      • asthma
      • diabetes
      • thyroid disease
    • glaucoma
    • cough that occurs 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 a prescription drug for
      • gout
      • diabetes
      • arthritis
    • 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

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • 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
    • ringing in the ears or loss of hearing occurs
    • 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.
    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than the recommended dose
    • do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product
    • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
    • children under 12 years: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: potassium 78 mg; sodium 356 mg
    • store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments? 1-800-986-0369 (Mon-

    Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer Plus®

    SEVERE COLD

    DAY/CITRUS

    NIGHT LEMON

    POWERFAST FIZZ™

    DAY NON-DROWSY

    ASPIRIN (NSAID)/Pain Reliever - Fever Reducer

    DEXTROMETHORPHAN HBr/Cough Suppressant

    PHENYLEPHRINE BITARTRATE/Nasal Decongestant

    • Nasal Decongestant
    • Headache + Body Ache
    • Cough
    • Sore Throat
    • Sinus Pressure

    12 EFFERVESCENT TABLETS

    NEW NIGHT DOSING DIRECTIONS

    NIGHT

    Aspirin (NSAID)/Pain Reliever-Fever Reducer

    Dextromethorphan HBr/Cough Suppressant

    Doxylamine Succinate/Antihistamine

    Phenylephrine Bitartrate/Nasal Decongestant

    • Nasal congestion
    • Headache + Body Ache
    • Cough
    • Runny Nose
    • Sore Throat

    8 EFFERVESCENT TABLETS

    Carton 20 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0086
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0086-011 in 1 CARTON; Type 0: Not a Combination Product04/29/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 132 POUCH 32 
    Part 216 POUCH 16 
    Part 1 of 2
    ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY 
    asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Item Code (Source)NDC:00280-0020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MANNITOL (UNII: 3OWL53L36A)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/29/2022
    Part 2 of 2
    ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ 
    aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Item Code (Source)NDC:0280-0068
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMONImprint Code ASP;NT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/27/2022
    Labeler - Bayer HealthCare LLC. (112117283)