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

  • NDC Code(s): 0280-1400-12, 0280-1400-20, 0280-1400-32, 0280-1400-36, view more
    0280-1400-48, 0280-1400-72
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 4, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purposes
    *
    nonsteroidal anti-inflammatory drug
    Aspirin 325 mg (NSAID) *Pain reliever/fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
    Phenylephrine bitartrate 7.8 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms due to a cold:
    • 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

    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

    When using this product

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

    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 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
    • 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.

  • 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

    • each tablet contains: sodium 474 mg
    • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
    • store at room temperature. Avoid excessive heat.
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • Questions or comments?

    1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

  • SPL UNCLASSIFIED SECTION

    Dist. by: Bayer HealthCare LLC
    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

    Alka-
    Seltzer
    PLUS ®
    Aspirin (NSAID) / Pain reliever-
    fever reducer • Chlorpheniramine
    maleate / Antihistamine • Phenylephrine
    bitartrate / Nasal decongestant

    COLD
    FORMULA

    SPARKLING
    ORIGINAL

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

    36 EFFERVESCENT TABLETS

    Principal Display Panel - 36 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL 
    aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1400
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code ALKA;SELTZER;PLUS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1400-126 in 1 CARTON04/10/200809/01/2011
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-1400-2010 in 1 CARTON04/10/200806/01/2019
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0280-1400-3216 in 1 CARTON04/10/2008
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0280-1400-3618 in 1 CARTON04/10/200806/01/2019
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0280-1400-4824 in 1 CARTON06/10/200806/01/2019
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0280-1400-7236 in 1 CARTON04/10/200812/01/2019
    62 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2008
    Labeler - Bayer HealthCare LLC. (112117283)