Label: ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY- asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent

  • NDC Code(s): 0280-0024-01, 0280-0024-02
  • 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 January 21, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    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

  • Uses

    Uses

    · temporarily relieves these symptoms due to a cold with cough:

    · minor aches and pains · headache · cough

    · nasal and sinus congestion · sore throat

    · 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

    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

    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 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

    Ask a doctor or pharmacist before use if you are

    · taking a prescription drug for

    · gout · diabetes · arthritis

    When using this product

    When using this product do not exceed recommended dosage

    Stop use

    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 a 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

    Pregnant or breast feeding

    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

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

  • Directions

    Directions

    ● 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 information

    Other information
    each tablet contains: potassium 80 mg; sodium 356 mg

    ● store at room temperature. Avoid excessive heat.

  • Inactive ingredients

    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)

  • Carton 20 count

    Alka-Seltzer Plus®

    SEVERE

    Cold

    CITRUS

    POWERFAST™ FIZZ

    NEW IMPROVED FLAVOR

    NON-DROWSY

    ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

    Dextromehorphan HBr / Cough Suppressant

    Phenylephrine Bitartrate / Nasal Decongestant

    • Fever + Body Ache
    • Nasal Congestion
    • Sinus Pressure
    • Sore Throat
    • Cough

    20 EFFERVESCENT TABLETS

    ASP Cold 1

    ASP Cold 2

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY 
    asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    Product Characteristics
    Colorwhite (Speckled) Scoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0024-0110 in 1 CARTON04/30/2020
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0024-0224 in 1 CARTON07/01/2022
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)