Label: ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

  • NDC Code(s): 0280-0060-01, 0280-0060-02, 0280-0060-03, 0280-0060-04, view more
    0280-0060-05, 0280-0060-06
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 21, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

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

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

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

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • Uses

    temporarily relieves these symptoms due to a cold:

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

    temporarily reduces fever

  • 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

    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 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

    ● difficulty in urination due to enlargement of the prostate gland

    ● a breathing problem such as emphysema or chronic bronchitis

    ● 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

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    taking sedatives or tranquilizers

    If pregnant or breast-feeding, ask a health professional before use.

    It is especially important not to use aspirin at 20 weeks or later in 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

    ● 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, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    ASP Severe Cold Sparkling Original 24ctAlka-Seltzer Plus®

    Severe Cold

    Sparkling Original

    POWERFAST FIZZ™

    NEW LESS RESIDUE

    ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

    Chlorpheniramine Maleate/Antihistamine

    Phenylephrine Bitartrate/Nasal Decongestant

    • Nasal Congestion
    • Runny Nose
    • Sore Throat
    • Headache + Body Ache
    • Sinus Pressure

    24 EFFERVESCENT TABLETS

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMONImprint Code ALKA;SELTZERplus
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0060-0110 in 1 CARTON06/15/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0060-0218 in 1 CARTON06/15/2021
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0280-0060-032 in 1 CARTON04/01/2022
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0280-0060-0412 in 1 CARTON03/30/2023
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0280-0060-052 in 1 POUCH; Type 0: Not a Combination Product06/15/2021
    6NDC:0280-0060-0624 in 1 CARTON03/30/2023
    62 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/15/2021
    Labeler - Bayer HealthCare LLC. (112117283)