ALKA-SELTZER PLUS COLD ORANGE ZEST (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]

ALKA-SELTZER PLUS COLD ORANGE ZEST (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]
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NDC 0280-1510-20
Set ID 53188c41-3f13-311b-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    Chlorpheniramine maleate 2 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    · temporarily relieves these symptoms due to a cold:

    · minor aches and pains · headache · 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

    ● difficulty in urination due to enlargement of the prostate gland

    ● a breathing problem such as emphysema or chronic bronchitis

    ● a sodium-restricted diet

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    · taking a prescription drug for

    · gout · diabetes · arthritis

    · taking sedatives or tranquilizers

  • WHEN USING

    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

    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 occur

  • 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.

  • 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: sodium 476 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, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    ALka-

    Seltzer®

    PLUS

    Cold

    ORANGE ZEST

    ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

    Chlorpheniramine Maleate/Antihistamine

    Phenylephrine Bitartrate/Nasal Decongestant

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

    20 EFFERVESCENT TABLETS

    Carton 20 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD ORANGE ZEST 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1510
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Colorwhite (White with orange and black flecks) Scoreno score
    ShapeROUNDSize25mm
    FlavorORANGEImprint Code Alka;Seltzer
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1510-2010 in 1 CARTON07/15/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/15/2017
    Labeler - Bayer HealthCare LLC. (112117283)

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