ALKA-SELTZER PLUS COLD AND COUGH (ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]

ALKA-SELTZER PLUS COLD AND COUGH (ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]
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NDC 0280-1555-20
Set ID 75862805-2cfe-fb45-e053-2991aa0a1403
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    Chlorpheniramine maleate 2 mg

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses

    Uses

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

     ·minor aches and pains  ·headache  ·cough

     ·runny nose  ·nasal and sinus congestion

     ·sneezing  ·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 to sedate children.

  • 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 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 ● diabetes ● thyroid disease ● 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

  • WHEN USING

    When using this product

    do not exceed recommended dosage

     may cause marked drowsiness

    ● avoid alcoholic drinks

    ● excitability may occur, especially in children

    ● alcohol, sedatives, and tranquilizers may increase drowsiness

    ● be careful when driving a motor vehicle or operating machinery

  • Stop use and ask a doctor if

    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

  • PREGNANCY 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 OF CHILDREN

    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: sodium 416 mg

    ● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, anhydrous citric

    acid, aspartame, calcium silicate, dimethicone, docusate sodium, FD&C

    red #40, flavors, mannitol, povidone, sodium benzoate, sodium

    bicarbonate

  • Questions or comments?

    Questions or comments?1-800-986-0369 (Mon - Fri 9AM -

    5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer

    PLUS®

    Cold &

    Cough

    CITRUS

    ASPIRIN (NSAID) / Pain Reliever/Fever Reducer

    Chlorpheniramine Maleate/Antihistamine

    Dextromethorphan HBr/Cough Suppresant

    Phenylephrine Bitartrate/Nasal Decongestant

    • Cough
    • Nasal Congestion
    • Runny Nose
    • Headache & Body Ache
    • Sinus Pressure

    20 EFFERVESCENT TABLETS

    Package label

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD AND COUGH 
    aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1555
    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
    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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;CandC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1555-2010 in 1 CARTON09/14/2018
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/14/2018
    Labeler - Bayer HealthCare LLC. (112117283)

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