ALKA-SELTZER PLUS COLD DAY AND NIGHT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE LLC.]

ALKA-SELTZER PLUS COLD DAY AND NIGHT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE LLC.]
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NDC 0280-1550-20
Set ID 75894849-a0ba-57be-e053-2a91aa0a049a
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Cold Day Effervescent Tablets

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

    Close
  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    Close
  • INDICATIONS & USAGE

    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

    Close
  • 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.

    Close
  • 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

    Close
  • 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 ● 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

    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ● taking a prescription drug for

     ● gout  ● diabetes  ● arthritis

    Close
  • WHEN USING

    When using this product do not exceed recommended dosage

    Close
  • 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 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

    Close
  • 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.

    Close
  • 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.

    Close
  • 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

    Close
  • Other information

    Other information

    each tablet contains: sodium 416 mg

    ● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

    ● store at room temperature. Avoid excessive heat

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, anhydrous citric

    acid, aspartame, calcium silicate, dimethicone, docusate sodium,

    flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

    Close
  • QUESTIONS

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

    5PM EST)

    Close
  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Cold Night Effervescent Tablets

    Close
  • SPL UNCLASSIFIED SECTION

    SPL

    Close
  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 500 mg (NSAID)*

    Dextromethorphan hydrobromide 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

    Close
  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

    Close
  • Uses

    Uses

     • temporarily relieves these symptoms due to a cold:

     • minor aches and pains  • headache  • runny nose

     • sinus congestion and pressure  • cough  • sneezing

     • sore throat  • nasal congestion

     • temporarily reduces fever

    Close
  • 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.

    Close
  • 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

    Close
  • 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

    Close
  • 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

    Close
  • WHEN USING

    When using this product

    ● do not exceed recommended dosage

     may cause marked drowsiness

    ● avoid alcoholic drinks

    ● alcohol, sedatives, and tranquilizers may increase drowsiness

    ● be careful when driving a motor vehicle or operating machinery

    ● excitability may occur, especially in children

    Close
  • 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 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

    Close
  • 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.

    Close
  • 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.

    Close
  • Directions

    Directions

    ● adults and children 12 years and over: take 2 tablets fully dissolved

    in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not

    exceed 8 tablets in 24 hours or as directed by a doctor.

    ● children under 12 years: do not use

    Close
  • Other information

    Other information

    ● each tablet contains: sodium 476 mg

    ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, anhydrous citric

    acid, aspartame, calcium silicate, dimethicone, docusate sodium,

    flavors (natural & artificial), mannitol, povidone, sodium benzoate,

    sodium bicarbonate

    Close
  • Questions or comments?

    Questions or comments?1-800-986-0369 (Mon-

    Fri 9AM – 5PM EST)

    Close
  • Package Display Label

    Alka-Seltzer

    PLUS®

    DAY NON-DROWSY

    ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

    Dextromethorphan HBr / Cough Suppressant

    Phenylephrine Bitartrate / Nasal Decongestant

    • Nasal Congestion
    • Headache & Body Ache
    • Cough
    • Sore Throat
    • Sinus Pressure

    12 EFFERVESCENT TABLETS

    NIGHT

    ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

    Dextromethorphan HBr / Cough Suppressant

    Doxylamine Succinate / Antihistamine

    Phenylephrine Bitartrate / Nasal Decongestant

    • Nasal Congestion
    • Headache & Body Ache
    • Cough
    • Runny nose
    • Sore Throat

    8 EFFERVESCENT TABLETS

    Carton labelProduct carton 2

    Close
  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD DAY AND NIGHT 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1550
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-1550-20 1 in 1 CARTON; Type 0: Not a Combination Product 09/14/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 6 POUCH 12 
    Part 2 4 POUCH
    Part 1 of 2
    ALKA-SELTZER PLUS COLD DAY 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor CITRUS Imprint Code ASP;DAY
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 6 in 1 CARTON
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/14/2018
    Part 2 of 2
    ALKA-SELTZER PLUS COLD NIGHT 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate tablet, effervescent
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MANNITOL (UNII: 3OWL53L36A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor LEMON Imprint Code ASP;NT
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 in 1 CARTON
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/14/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/14/2018
    Labeler - Bayer HealthCare LLC. (112117283)
    Close

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